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Thermo-Fractional PDT Destroys Persistent Warts

Article Type
Changed
Fri, 01/11/2019 - 11:41
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Thermo-Fractional PDT Destroys Persistent Warts

Laser-induced thermotherapy combined with a fractional laser successfully eradicated the majority of persistent warts in a study of 20 patients.

Subclinical infection with human papillomavirus verruca vulgaris infection (due to HPV types 1, 2, and 4) and condyloma acuminata (due to HPV types 6 and 11) often persists after eradication.

Photo courtesy Dr. Leonardo Marini
    A patient with a digital wart is shown before undergoing thermo-fractional photodynamic therapy. the same patient is shown 6 months after treatment.

Photodynamic therapy (PDT) with topical application of 5-aminolevulinic acid (5-ALA) has previously been shown to be an effective treatment for such warts located in difficult anatomic areas, said Dr. Leonardo Marini, who is in private practice in Trieste, Italy.

However, 5-ALA cannot penetrate deeply into the skin. Therefore, it only has U.S. Food and Drug Administration approval for superficial skin neoplasms, such as multifocal basal cell carcinomas, actinic keratoses, and Bowen's disease.

New strategies for increasing penetration through the stratum corneum include needling and ablative fractional lasers.

Animal data have confirmed the validity of CO2 lasers, showing that transcutaneous microchannels stay open up to 7 hours after a fractional laser procedure. "This opens new horizons for all kinds of topical treatments," Dr. Marini said in an interview.

Photo courtesy Dr. Leonardo Marini
    The patient's finger is shown 6 months after undergoing thermo-fractional photodynamic therapy.

Thermotherapy performed with an Nd:YAG laser has a damaging effect on viral entities and increases cutaneous reactive circulation, optimizing the conversion of 5-ALA to protoporphyrin IX (PpIX), which is the active light absorber in PDT. "This is why I called the procedure 'thermo-fractional PDT,' " he explained.

His study investigated the sequential combination of 1,064-nm thermotherapy and ablative fractional resurfacing with one of two different types of lasers – CO2 or 2,904-nm Er:YAG – as active trans–stratum corneum penetration enhancers prior to topical application of 5-ALA gel and followed by light-emitting diode (LED) irradiation, he said.

The 10 men and 10 women with resistant plantar and/or digital warts had a mean age of 21 years (range 12-37 years) and Fitzpatrick skin types II-III.

Initially, all the patients' lesions (a total of 57) were treated with full-field, 2,940-nm Er:YAG laser photovaporization to eliminate secondary hyperkeratotic growths.

Then, pre-ALA thermotherapy was performed with three sequential passes of a long-pulse 1064-nm Nd:YAG laser (3-mm spot, 35 ms, 50 J/cm2).

Next, 32 lesions were pretreated with the 2,940-nm Er:YAG laser (0.250-mm spot, 0.175 ms, 12 J/ cm2), while the other 25 warts were treated with a 10.600-nm CO2 ablative fractional laser (0.300-mm spot, 0.900 ms, 14 W).

Ten percent 5-ALA liposome gel was then immediately applied to all lesions and occluded under polyurethane film for 6 hours. Digital blocks and/or infiltration anesthesia with 2% plain mepivacaine were given, and all treated areas received irradiation with a 633-nm LED divided in two sequential exposures of 4 and 16 minutes, separated by a 20-minute interval, Dr. Marini reported.

All of the patients experienced intense post-PDT activation pain immediately after fading of local anesthesia, with a peak level reported at 24 hours postoperatively. Nearly three-quarters of the patients required oral painkillers. The pain progressively faded over the next 48 hours, he noted.

Clinical eradication was achieved at 3 months in 90% of lesions.

No differences were observed between the two different fractional lasers as trans–corneal-intradermal penetration enhancers. No postoperative scarring or infections were observed. Transitory postinflammatory hyperpigmentation occurred on the dorsal hands of two patients in the Er:YAG laser group and two in the CO2 laser group.

No clinical recurrences were observed at 6 months postoperatively.

More studies are needed to determine the optimal treatment timing and sequence, Dr. Marini concluded.

He presented his findings at the annual meeting of the American Society for Laser Medicine and Surgery.

Dr. Marini stated that Deka and Fotona contributed equipment for the study. He had no other conflicts of interest to disclose.

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Dr. Leonardo Marini, PDT, lasers, warts, digital warts, 5-aminolevulinic acid, 5-ALA, HPV, Photodynamic therapy, CO2 laser, human papillomavirus verruca vulgaris infection, 5-ALA, Er:YAG laser
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Laser-induced thermotherapy combined with a fractional laser successfully eradicated the majority of persistent warts in a study of 20 patients.

Subclinical infection with human papillomavirus verruca vulgaris infection (due to HPV types 1, 2, and 4) and condyloma acuminata (due to HPV types 6 and 11) often persists after eradication.

Photo courtesy Dr. Leonardo Marini
    A patient with a digital wart is shown before undergoing thermo-fractional photodynamic therapy. the same patient is shown 6 months after treatment.

Photodynamic therapy (PDT) with topical application of 5-aminolevulinic acid (5-ALA) has previously been shown to be an effective treatment for such warts located in difficult anatomic areas, said Dr. Leonardo Marini, who is in private practice in Trieste, Italy.

However, 5-ALA cannot penetrate deeply into the skin. Therefore, it only has U.S. Food and Drug Administration approval for superficial skin neoplasms, such as multifocal basal cell carcinomas, actinic keratoses, and Bowen's disease.

New strategies for increasing penetration through the stratum corneum include needling and ablative fractional lasers.

Animal data have confirmed the validity of CO2 lasers, showing that transcutaneous microchannels stay open up to 7 hours after a fractional laser procedure. "This opens new horizons for all kinds of topical treatments," Dr. Marini said in an interview.

Photo courtesy Dr. Leonardo Marini
    The patient's finger is shown 6 months after undergoing thermo-fractional photodynamic therapy.

Thermotherapy performed with an Nd:YAG laser has a damaging effect on viral entities and increases cutaneous reactive circulation, optimizing the conversion of 5-ALA to protoporphyrin IX (PpIX), which is the active light absorber in PDT. "This is why I called the procedure 'thermo-fractional PDT,' " he explained.

His study investigated the sequential combination of 1,064-nm thermotherapy and ablative fractional resurfacing with one of two different types of lasers – CO2 or 2,904-nm Er:YAG – as active trans–stratum corneum penetration enhancers prior to topical application of 5-ALA gel and followed by light-emitting diode (LED) irradiation, he said.

The 10 men and 10 women with resistant plantar and/or digital warts had a mean age of 21 years (range 12-37 years) and Fitzpatrick skin types II-III.

Initially, all the patients' lesions (a total of 57) were treated with full-field, 2,940-nm Er:YAG laser photovaporization to eliminate secondary hyperkeratotic growths.

Then, pre-ALA thermotherapy was performed with three sequential passes of a long-pulse 1064-nm Nd:YAG laser (3-mm spot, 35 ms, 50 J/cm2).

Next, 32 lesions were pretreated with the 2,940-nm Er:YAG laser (0.250-mm spot, 0.175 ms, 12 J/ cm2), while the other 25 warts were treated with a 10.600-nm CO2 ablative fractional laser (0.300-mm spot, 0.900 ms, 14 W).

Ten percent 5-ALA liposome gel was then immediately applied to all lesions and occluded under polyurethane film for 6 hours. Digital blocks and/or infiltration anesthesia with 2% plain mepivacaine were given, and all treated areas received irradiation with a 633-nm LED divided in two sequential exposures of 4 and 16 minutes, separated by a 20-minute interval, Dr. Marini reported.

All of the patients experienced intense post-PDT activation pain immediately after fading of local anesthesia, with a peak level reported at 24 hours postoperatively. Nearly three-quarters of the patients required oral painkillers. The pain progressively faded over the next 48 hours, he noted.

Clinical eradication was achieved at 3 months in 90% of lesions.

No differences were observed between the two different fractional lasers as trans–corneal-intradermal penetration enhancers. No postoperative scarring or infections were observed. Transitory postinflammatory hyperpigmentation occurred on the dorsal hands of two patients in the Er:YAG laser group and two in the CO2 laser group.

No clinical recurrences were observed at 6 months postoperatively.

More studies are needed to determine the optimal treatment timing and sequence, Dr. Marini concluded.

He presented his findings at the annual meeting of the American Society for Laser Medicine and Surgery.

Dr. Marini stated that Deka and Fotona contributed equipment for the study. He had no other conflicts of interest to disclose.

Laser-induced thermotherapy combined with a fractional laser successfully eradicated the majority of persistent warts in a study of 20 patients.

Subclinical infection with human papillomavirus verruca vulgaris infection (due to HPV types 1, 2, and 4) and condyloma acuminata (due to HPV types 6 and 11) often persists after eradication.

Photo courtesy Dr. Leonardo Marini
    A patient with a digital wart is shown before undergoing thermo-fractional photodynamic therapy. the same patient is shown 6 months after treatment.

Photodynamic therapy (PDT) with topical application of 5-aminolevulinic acid (5-ALA) has previously been shown to be an effective treatment for such warts located in difficult anatomic areas, said Dr. Leonardo Marini, who is in private practice in Trieste, Italy.

However, 5-ALA cannot penetrate deeply into the skin. Therefore, it only has U.S. Food and Drug Administration approval for superficial skin neoplasms, such as multifocal basal cell carcinomas, actinic keratoses, and Bowen's disease.

New strategies for increasing penetration through the stratum corneum include needling and ablative fractional lasers.

Animal data have confirmed the validity of CO2 lasers, showing that transcutaneous microchannels stay open up to 7 hours after a fractional laser procedure. "This opens new horizons for all kinds of topical treatments," Dr. Marini said in an interview.

Photo courtesy Dr. Leonardo Marini
    The patient's finger is shown 6 months after undergoing thermo-fractional photodynamic therapy.

Thermotherapy performed with an Nd:YAG laser has a damaging effect on viral entities and increases cutaneous reactive circulation, optimizing the conversion of 5-ALA to protoporphyrin IX (PpIX), which is the active light absorber in PDT. "This is why I called the procedure 'thermo-fractional PDT,' " he explained.

His study investigated the sequential combination of 1,064-nm thermotherapy and ablative fractional resurfacing with one of two different types of lasers – CO2 or 2,904-nm Er:YAG – as active trans–stratum corneum penetration enhancers prior to topical application of 5-ALA gel and followed by light-emitting diode (LED) irradiation, he said.

The 10 men and 10 women with resistant plantar and/or digital warts had a mean age of 21 years (range 12-37 years) and Fitzpatrick skin types II-III.

Initially, all the patients' lesions (a total of 57) were treated with full-field, 2,940-nm Er:YAG laser photovaporization to eliminate secondary hyperkeratotic growths.

Then, pre-ALA thermotherapy was performed with three sequential passes of a long-pulse 1064-nm Nd:YAG laser (3-mm spot, 35 ms, 50 J/cm2).

Next, 32 lesions were pretreated with the 2,940-nm Er:YAG laser (0.250-mm spot, 0.175 ms, 12 J/ cm2), while the other 25 warts were treated with a 10.600-nm CO2 ablative fractional laser (0.300-mm spot, 0.900 ms, 14 W).

Ten percent 5-ALA liposome gel was then immediately applied to all lesions and occluded under polyurethane film for 6 hours. Digital blocks and/or infiltration anesthesia with 2% plain mepivacaine were given, and all treated areas received irradiation with a 633-nm LED divided in two sequential exposures of 4 and 16 minutes, separated by a 20-minute interval, Dr. Marini reported.

All of the patients experienced intense post-PDT activation pain immediately after fading of local anesthesia, with a peak level reported at 24 hours postoperatively. Nearly three-quarters of the patients required oral painkillers. The pain progressively faded over the next 48 hours, he noted.

Clinical eradication was achieved at 3 months in 90% of lesions.

No differences were observed between the two different fractional lasers as trans–corneal-intradermal penetration enhancers. No postoperative scarring or infections were observed. Transitory postinflammatory hyperpigmentation occurred on the dorsal hands of two patients in the Er:YAG laser group and two in the CO2 laser group.

No clinical recurrences were observed at 6 months postoperatively.

More studies are needed to determine the optimal treatment timing and sequence, Dr. Marini concluded.

He presented his findings at the annual meeting of the American Society for Laser Medicine and Surgery.

Dr. Marini stated that Deka and Fotona contributed equipment for the study. He had no other conflicts of interest to disclose.

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Thermo-Fractional PDT Destroys Persistent Warts
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Thermo-Fractional PDT Destroys Persistent Warts
Legacy Keywords
Dr. Leonardo Marini, PDT, lasers, warts, digital warts, 5-aminolevulinic acid, 5-ALA, HPV, Photodynamic therapy, CO2 laser, human papillomavirus verruca vulgaris infection, 5-ALA, Er:YAG laser
Legacy Keywords
Dr. Leonardo Marini, PDT, lasers, warts, digital warts, 5-aminolevulinic acid, 5-ALA, HPV, Photodynamic therapy, CO2 laser, human papillomavirus verruca vulgaris infection, 5-ALA, Er:YAG laser
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Medical, Cosmetic Dermatologists Agree: Health Before Beauty

Article Type
Changed
Fri, 06/11/2021 - 10:22
Display Headline
Medical, Cosmetic Dermatologists Agree: Health Before Beauty

Medical and cosmetic dermatologists may bring different views to the discussion of skin care, but they do agree on one thing – health should always come before beauty.

Basic dermatologic health procedures, like total body skin checks, mole assessment, and sun exposure advice, should be the foundation of any cosmetic dermatologist's work. No amount of wrinkle reduction, laser resurfacing, or complexion correction can ever make up for a missed skin cancer, according to cosmetic dermatologists.

Jay Mallin/Elsevier Global Medical News
Dr. Elizabeth Tanzi treats a patient.    

"I take this responsibility very seriously," said Dr. Elizabeth Tanzi, a Washington, D.C. dermatologist who specializes in laser surgery. "All our patients, whether new or returning, get a full head-to-toe exam for skin cancer. It would be tragic to be talking about wrinkles and crepey skin when there’s a skin cancer."

Dr. Tanzi said that health should be center of any dermatologic procedure – and that cosmetic procedures are no exception.

"We have to look at it like this: Number one, make sure your skin is healthy. Number two: beautify it."

Dermatologic practices are split into three categories: all cosmetic, all medical, or a combination of the two. Purely medical dermatologists tend to cluster in academic institutions, while purely cosmetic dermatologists are most often seen in large cities. Dual-therapy dermatologists are the workhorses who serve most communities.

All dermatologists need to know when to proceed and when to say "no," Dr. Tanzi said. Referral to a medical dermatologist may cost a patient in the short term, but will serve everyone well in the long term.

"If a patient comes to me with an issue in my area of expertise and I know I can do a great job, I’ll take it," said Dr. Tanzi, codirector of the Washington Institute of Dermatologic Laser Surgery. "If they come in with something where I’m not up on the latest, or something I haven't seen in years and feel I won’t be best for the job, I refer. An urban setting really allows this to happen. In D.C. we have the luxury of saying that there is someone nearby who is an expert in any field. It is a different story in communities where you need to be a jack of all trades."

A Jack of All Trades

Dr. Margaret "Peggy" Fitch fills that bill. "I’m a surgical and cosmetic dermatologist in the morning and a medical dermatologist in the afternoon," said Dr. Fitch, founder of Aiken Dermatology, Aiken, S.C.

She didn't always split her time between the disciplines, however. When she began practicing 30 years ago, she focused on medical and surgical dermatology. Then things began to change.

"Over time, peels, fillers, Botox, and sclerotherapy came along. They were on the front page of Cosmopolitan. Patients were asking about them. And I was seeing the results of bad outcomes – procedures done by physicians who shouldn’t have been doing them."

Taking a weekend course in a cosmetic procedure does not make an expert, Dr. Fitch said.

"Let’s be honest – there are lots of doctors out there who do this just to make a quick buck, and I was seeing the results of that. So I thought, 'I'm a dermatologist. I know skin and the anatomic structure of the face. I should be doing this.' So gradually I learned and added to my practice."

She doesn't shy away from discussing the financial benefits of cosmetic work.

"Sure, it's a revenue builder. But I let patients decide what they want. If someone comes to me for a medical issue, I will never, ever bring up a cosmetic issue. I think that is foraging in the forest for a buck. If a patient asks about Botox while we're talking, that's another issue. But as a doctor, I would never bring up someone’s wrinkles."

She isn’t afraid to say "no" either. "I say no all the time. I’m not above saying, 'Look you don’t need this.' "

For example, she said, a 27-year-old bride-to-be asked her for filler for her lips. Dr. Fitch refused, telling her the lines were too fine to be treated, and that she was too young to be looking at the procedure. "I could have made $500 for that. But I think I'm the exception to the rule here. Most people would have gone and done it."

As a surgical dermatologist, she concentrates on skin cancers, using her own in-office pathology lab to assess the specimens. "I do flaps and grafts, but I would never attempt a full Mohs. That’s all part of knowing when you must say to a patient, 'I'm a good doctor and a good surgeon, but I'm not the best person for this.' "

 

 

Taking on New Roles

Dr. Sue Ellen Cox is another dermatologist who enjoys mixing it up. While 80% of her practice is cosmetic, the rest of her patients have medical issues. "If a patient comes to me and doesn't already have a general dermatologist, I'll take on that role without a problem. I really enjoy doing that – it gives me some variety and keeps me sharp."

When she began her 16-year-old practice in Chapel Hill, N.C., she did outreach to local dermatologists. With several years of specialized training in collagen, lasers, and liposuction, and a research study on chemical peels, Dr. Cox felt like she could bring something new and valuable to the medical community.

"I went to all the dermatologists in the area and told them about my specialized training and asked them to send me any cosmetic cases they weren't comfortable with. My practice just took off from there," she said.

At the same time, she never bites the hand that feeds her. "If someone is referred to me for laser and I see a basal cell carcinoma, for example, I'll tell them to talk to their referring physician before I do anything. Referrals are a lifeline, and I don't want to cut that."

Dermatologists who combine both medical and cosmetic work need to be scrupulous in their billing, she warned.

"If I'm doing a laser treatment for rosacea, that's a fee for service procedure. If I'm diagnosing rosacea for the first time, I bill insurance. If I diagnose lentigoes and precancerous lesions and treat them, I bill insurance. But if the main benefit is cosmetic, it's self pay. The same with moles – removal of a benign mole for cosmetic reasons is one thing, removal and biopsy of a suspicious mole is another."

"We Treat Cosmetic Issues, Not Health Issues"

Dr. Eliot Battle has no issues with insurance billing. As a completely cosmetic dermatologist, his business is all self pay. And his patients know that from the beginning.

    Dr. Eliot Battle

"There is no confusion about what we do. We treat cosmetic issues – not health issues. I don't take insurance, and our advertising and website are very clear about this. If we see someone with medical issues, we push them to a medical dermatologist – that saves them money, and we know that medical derms are better for these things than we would ever be."

Dr. Battle has built his practice on four areas – laser hair removal, complexion blending, textural rejuvenation, and antiaging procedures. About 100 patients, primarily women, come through his office every day, 6 days a week. Dr. Battle specializes in treating darker skin, which is much more prone to the scarring and pigmentation changes that can result from inexpert cosmetic treatment.

Dr. Battle does few of the procedures. He conducts all of the consultations and designs the treatment plans, but registered nurses perform the procedures. "I work with six full-time nurses, who undergo a strict internal training program and participate in ongoing medical education. I send them to every possible meeting that could be of help, and I support all this education financially."

Dr. Battle brings a unique set of business skills to his medical practice. After working as a marketing director for a large computer firm, he decided to enroll in medical school.

"I took my first science course at age 33 and was a dermatology resident at age 41," he said. "When I finally finished, my passion was cosmetic dermatology. At that point lasers were still in their infancy, and I worked for 3 years in research about laser safety – especially for skin of color."

He designed his cosmetic work as not only a practice but as a business, with his children's future in mind. "I wanted to make sure they could inherit my own success," he said. "Children cannot inherit a physician's practice, but they can inherit a business." Dr. Battle does not treat patients himself, so the Cultura Cosmetic Dermatology and Laser Center in Washington, is considered a business rather than a practice.

Because he offers limited procedures, his staff has become expert in performing them, he said. But when he encounters anything beyond what he is prepared to offer, Dr. Battle refers to a medical dermatologist.

"My medical oath says to do no harm, and that rules all that I do. We are always looking out for the patient's best interest. If I see a suspicious mole or a concerning flare of lupus, I refer. I am not geared to help that person."

 

 

Dr. Battle hasn't completely foresworn either medical or academic work, however. He conducts research at Howard University, Washington, and teaches residents who are interested in cosmetic dermatology.

His business background puts him in a position to offer business advice, and his age, he said, allows him to give personal counsel as well.

"One thing I tell residents is that just because they might generate a lot of revenue with a cosmetic practice doesn't necessarily mean they'll generate a lot of profit. It's also important for people to be true to themselves. I encourage them to look deeply into this and not be blinded by the idea that they'll make tons of money doing cosmetic work. A lot of residents really enjoy the academic side of medicine, and cosmetic dermatology will not bring them that. If academics are your passion, you should not forego that for the temporary dollar."

Dr. Tanzi is on the medical advisory board for Zeltiq. Dr. Cox is a consultant for Medisys and Allergan. Dr. Battle and Dr. Fitch reported having no conflicts of interest.

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Medical and cosmetic dermatologists may bring different views to the discussion of skin care, but they do agree on one thing – health should always come before beauty.

Basic dermatologic health procedures, like total body skin checks, mole assessment, and sun exposure advice, should be the foundation of any cosmetic dermatologist's work. No amount of wrinkle reduction, laser resurfacing, or complexion correction can ever make up for a missed skin cancer, according to cosmetic dermatologists.

Jay Mallin/Elsevier Global Medical News
Dr. Elizabeth Tanzi treats a patient.    

"I take this responsibility very seriously," said Dr. Elizabeth Tanzi, a Washington, D.C. dermatologist who specializes in laser surgery. "All our patients, whether new or returning, get a full head-to-toe exam for skin cancer. It would be tragic to be talking about wrinkles and crepey skin when there’s a skin cancer."

Dr. Tanzi said that health should be center of any dermatologic procedure – and that cosmetic procedures are no exception.

"We have to look at it like this: Number one, make sure your skin is healthy. Number two: beautify it."

Dermatologic practices are split into three categories: all cosmetic, all medical, or a combination of the two. Purely medical dermatologists tend to cluster in academic institutions, while purely cosmetic dermatologists are most often seen in large cities. Dual-therapy dermatologists are the workhorses who serve most communities.

All dermatologists need to know when to proceed and when to say "no," Dr. Tanzi said. Referral to a medical dermatologist may cost a patient in the short term, but will serve everyone well in the long term.

"If a patient comes to me with an issue in my area of expertise and I know I can do a great job, I’ll take it," said Dr. Tanzi, codirector of the Washington Institute of Dermatologic Laser Surgery. "If they come in with something where I’m not up on the latest, or something I haven't seen in years and feel I won’t be best for the job, I refer. An urban setting really allows this to happen. In D.C. we have the luxury of saying that there is someone nearby who is an expert in any field. It is a different story in communities where you need to be a jack of all trades."

A Jack of All Trades

Dr. Margaret "Peggy" Fitch fills that bill. "I’m a surgical and cosmetic dermatologist in the morning and a medical dermatologist in the afternoon," said Dr. Fitch, founder of Aiken Dermatology, Aiken, S.C.

She didn't always split her time between the disciplines, however. When she began practicing 30 years ago, she focused on medical and surgical dermatology. Then things began to change.

"Over time, peels, fillers, Botox, and sclerotherapy came along. They were on the front page of Cosmopolitan. Patients were asking about them. And I was seeing the results of bad outcomes – procedures done by physicians who shouldn’t have been doing them."

Taking a weekend course in a cosmetic procedure does not make an expert, Dr. Fitch said.

"Let’s be honest – there are lots of doctors out there who do this just to make a quick buck, and I was seeing the results of that. So I thought, 'I'm a dermatologist. I know skin and the anatomic structure of the face. I should be doing this.' So gradually I learned and added to my practice."

She doesn't shy away from discussing the financial benefits of cosmetic work.

"Sure, it's a revenue builder. But I let patients decide what they want. If someone comes to me for a medical issue, I will never, ever bring up a cosmetic issue. I think that is foraging in the forest for a buck. If a patient asks about Botox while we're talking, that's another issue. But as a doctor, I would never bring up someone’s wrinkles."

She isn’t afraid to say "no" either. "I say no all the time. I’m not above saying, 'Look you don’t need this.' "

For example, she said, a 27-year-old bride-to-be asked her for filler for her lips. Dr. Fitch refused, telling her the lines were too fine to be treated, and that she was too young to be looking at the procedure. "I could have made $500 for that. But I think I'm the exception to the rule here. Most people would have gone and done it."

As a surgical dermatologist, she concentrates on skin cancers, using her own in-office pathology lab to assess the specimens. "I do flaps and grafts, but I would never attempt a full Mohs. That’s all part of knowing when you must say to a patient, 'I'm a good doctor and a good surgeon, but I'm not the best person for this.' "

 

 

Taking on New Roles

Dr. Sue Ellen Cox is another dermatologist who enjoys mixing it up. While 80% of her practice is cosmetic, the rest of her patients have medical issues. "If a patient comes to me and doesn't already have a general dermatologist, I'll take on that role without a problem. I really enjoy doing that – it gives me some variety and keeps me sharp."

When she began her 16-year-old practice in Chapel Hill, N.C., she did outreach to local dermatologists. With several years of specialized training in collagen, lasers, and liposuction, and a research study on chemical peels, Dr. Cox felt like she could bring something new and valuable to the medical community.

"I went to all the dermatologists in the area and told them about my specialized training and asked them to send me any cosmetic cases they weren't comfortable with. My practice just took off from there," she said.

At the same time, she never bites the hand that feeds her. "If someone is referred to me for laser and I see a basal cell carcinoma, for example, I'll tell them to talk to their referring physician before I do anything. Referrals are a lifeline, and I don't want to cut that."

Dermatologists who combine both medical and cosmetic work need to be scrupulous in their billing, she warned.

"If I'm doing a laser treatment for rosacea, that's a fee for service procedure. If I'm diagnosing rosacea for the first time, I bill insurance. If I diagnose lentigoes and precancerous lesions and treat them, I bill insurance. But if the main benefit is cosmetic, it's self pay. The same with moles – removal of a benign mole for cosmetic reasons is one thing, removal and biopsy of a suspicious mole is another."

"We Treat Cosmetic Issues, Not Health Issues"

Dr. Eliot Battle has no issues with insurance billing. As a completely cosmetic dermatologist, his business is all self pay. And his patients know that from the beginning.

    Dr. Eliot Battle

"There is no confusion about what we do. We treat cosmetic issues – not health issues. I don't take insurance, and our advertising and website are very clear about this. If we see someone with medical issues, we push them to a medical dermatologist – that saves them money, and we know that medical derms are better for these things than we would ever be."

Dr. Battle has built his practice on four areas – laser hair removal, complexion blending, textural rejuvenation, and antiaging procedures. About 100 patients, primarily women, come through his office every day, 6 days a week. Dr. Battle specializes in treating darker skin, which is much more prone to the scarring and pigmentation changes that can result from inexpert cosmetic treatment.

Dr. Battle does few of the procedures. He conducts all of the consultations and designs the treatment plans, but registered nurses perform the procedures. "I work with six full-time nurses, who undergo a strict internal training program and participate in ongoing medical education. I send them to every possible meeting that could be of help, and I support all this education financially."

Dr. Battle brings a unique set of business skills to his medical practice. After working as a marketing director for a large computer firm, he decided to enroll in medical school.

"I took my first science course at age 33 and was a dermatology resident at age 41," he said. "When I finally finished, my passion was cosmetic dermatology. At that point lasers were still in their infancy, and I worked for 3 years in research about laser safety – especially for skin of color."

He designed his cosmetic work as not only a practice but as a business, with his children's future in mind. "I wanted to make sure they could inherit my own success," he said. "Children cannot inherit a physician's practice, but they can inherit a business." Dr. Battle does not treat patients himself, so the Cultura Cosmetic Dermatology and Laser Center in Washington, is considered a business rather than a practice.

Because he offers limited procedures, his staff has become expert in performing them, he said. But when he encounters anything beyond what he is prepared to offer, Dr. Battle refers to a medical dermatologist.

"My medical oath says to do no harm, and that rules all that I do. We are always looking out for the patient's best interest. If I see a suspicious mole or a concerning flare of lupus, I refer. I am not geared to help that person."

 

 

Dr. Battle hasn't completely foresworn either medical or academic work, however. He conducts research at Howard University, Washington, and teaches residents who are interested in cosmetic dermatology.

His business background puts him in a position to offer business advice, and his age, he said, allows him to give personal counsel as well.

"One thing I tell residents is that just because they might generate a lot of revenue with a cosmetic practice doesn't necessarily mean they'll generate a lot of profit. It's also important for people to be true to themselves. I encourage them to look deeply into this and not be blinded by the idea that they'll make tons of money doing cosmetic work. A lot of residents really enjoy the academic side of medicine, and cosmetic dermatology will not bring them that. If academics are your passion, you should not forego that for the temporary dollar."

Dr. Tanzi is on the medical advisory board for Zeltiq. Dr. Cox is a consultant for Medisys and Allergan. Dr. Battle and Dr. Fitch reported having no conflicts of interest.

Medical and cosmetic dermatologists may bring different views to the discussion of skin care, but they do agree on one thing – health should always come before beauty.

Basic dermatologic health procedures, like total body skin checks, mole assessment, and sun exposure advice, should be the foundation of any cosmetic dermatologist's work. No amount of wrinkle reduction, laser resurfacing, or complexion correction can ever make up for a missed skin cancer, according to cosmetic dermatologists.

Jay Mallin/Elsevier Global Medical News
Dr. Elizabeth Tanzi treats a patient.    

"I take this responsibility very seriously," said Dr. Elizabeth Tanzi, a Washington, D.C. dermatologist who specializes in laser surgery. "All our patients, whether new or returning, get a full head-to-toe exam for skin cancer. It would be tragic to be talking about wrinkles and crepey skin when there’s a skin cancer."

Dr. Tanzi said that health should be center of any dermatologic procedure – and that cosmetic procedures are no exception.

"We have to look at it like this: Number one, make sure your skin is healthy. Number two: beautify it."

Dermatologic practices are split into three categories: all cosmetic, all medical, or a combination of the two. Purely medical dermatologists tend to cluster in academic institutions, while purely cosmetic dermatologists are most often seen in large cities. Dual-therapy dermatologists are the workhorses who serve most communities.

All dermatologists need to know when to proceed and when to say "no," Dr. Tanzi said. Referral to a medical dermatologist may cost a patient in the short term, but will serve everyone well in the long term.

"If a patient comes to me with an issue in my area of expertise and I know I can do a great job, I’ll take it," said Dr. Tanzi, codirector of the Washington Institute of Dermatologic Laser Surgery. "If they come in with something where I’m not up on the latest, or something I haven't seen in years and feel I won’t be best for the job, I refer. An urban setting really allows this to happen. In D.C. we have the luxury of saying that there is someone nearby who is an expert in any field. It is a different story in communities where you need to be a jack of all trades."

A Jack of All Trades

Dr. Margaret "Peggy" Fitch fills that bill. "I’m a surgical and cosmetic dermatologist in the morning and a medical dermatologist in the afternoon," said Dr. Fitch, founder of Aiken Dermatology, Aiken, S.C.

She didn't always split her time between the disciplines, however. When she began practicing 30 years ago, she focused on medical and surgical dermatology. Then things began to change.

"Over time, peels, fillers, Botox, and sclerotherapy came along. They were on the front page of Cosmopolitan. Patients were asking about them. And I was seeing the results of bad outcomes – procedures done by physicians who shouldn’t have been doing them."

Taking a weekend course in a cosmetic procedure does not make an expert, Dr. Fitch said.

"Let’s be honest – there are lots of doctors out there who do this just to make a quick buck, and I was seeing the results of that. So I thought, 'I'm a dermatologist. I know skin and the anatomic structure of the face. I should be doing this.' So gradually I learned and added to my practice."

She doesn't shy away from discussing the financial benefits of cosmetic work.

"Sure, it's a revenue builder. But I let patients decide what they want. If someone comes to me for a medical issue, I will never, ever bring up a cosmetic issue. I think that is foraging in the forest for a buck. If a patient asks about Botox while we're talking, that's another issue. But as a doctor, I would never bring up someone’s wrinkles."

She isn’t afraid to say "no" either. "I say no all the time. I’m not above saying, 'Look you don’t need this.' "

For example, she said, a 27-year-old bride-to-be asked her for filler for her lips. Dr. Fitch refused, telling her the lines were too fine to be treated, and that she was too young to be looking at the procedure. "I could have made $500 for that. But I think I'm the exception to the rule here. Most people would have gone and done it."

As a surgical dermatologist, she concentrates on skin cancers, using her own in-office pathology lab to assess the specimens. "I do flaps and grafts, but I would never attempt a full Mohs. That’s all part of knowing when you must say to a patient, 'I'm a good doctor and a good surgeon, but I'm not the best person for this.' "

 

 

Taking on New Roles

Dr. Sue Ellen Cox is another dermatologist who enjoys mixing it up. While 80% of her practice is cosmetic, the rest of her patients have medical issues. "If a patient comes to me and doesn't already have a general dermatologist, I'll take on that role without a problem. I really enjoy doing that – it gives me some variety and keeps me sharp."

When she began her 16-year-old practice in Chapel Hill, N.C., she did outreach to local dermatologists. With several years of specialized training in collagen, lasers, and liposuction, and a research study on chemical peels, Dr. Cox felt like she could bring something new and valuable to the medical community.

"I went to all the dermatologists in the area and told them about my specialized training and asked them to send me any cosmetic cases they weren't comfortable with. My practice just took off from there," she said.

At the same time, she never bites the hand that feeds her. "If someone is referred to me for laser and I see a basal cell carcinoma, for example, I'll tell them to talk to their referring physician before I do anything. Referrals are a lifeline, and I don't want to cut that."

Dermatologists who combine both medical and cosmetic work need to be scrupulous in their billing, she warned.

"If I'm doing a laser treatment for rosacea, that's a fee for service procedure. If I'm diagnosing rosacea for the first time, I bill insurance. If I diagnose lentigoes and precancerous lesions and treat them, I bill insurance. But if the main benefit is cosmetic, it's self pay. The same with moles – removal of a benign mole for cosmetic reasons is one thing, removal and biopsy of a suspicious mole is another."

"We Treat Cosmetic Issues, Not Health Issues"

Dr. Eliot Battle has no issues with insurance billing. As a completely cosmetic dermatologist, his business is all self pay. And his patients know that from the beginning.

    Dr. Eliot Battle

"There is no confusion about what we do. We treat cosmetic issues – not health issues. I don't take insurance, and our advertising and website are very clear about this. If we see someone with medical issues, we push them to a medical dermatologist – that saves them money, and we know that medical derms are better for these things than we would ever be."

Dr. Battle has built his practice on four areas – laser hair removal, complexion blending, textural rejuvenation, and antiaging procedures. About 100 patients, primarily women, come through his office every day, 6 days a week. Dr. Battle specializes in treating darker skin, which is much more prone to the scarring and pigmentation changes that can result from inexpert cosmetic treatment.

Dr. Battle does few of the procedures. He conducts all of the consultations and designs the treatment plans, but registered nurses perform the procedures. "I work with six full-time nurses, who undergo a strict internal training program and participate in ongoing medical education. I send them to every possible meeting that could be of help, and I support all this education financially."

Dr. Battle brings a unique set of business skills to his medical practice. After working as a marketing director for a large computer firm, he decided to enroll in medical school.

"I took my first science course at age 33 and was a dermatology resident at age 41," he said. "When I finally finished, my passion was cosmetic dermatology. At that point lasers were still in their infancy, and I worked for 3 years in research about laser safety – especially for skin of color."

He designed his cosmetic work as not only a practice but as a business, with his children's future in mind. "I wanted to make sure they could inherit my own success," he said. "Children cannot inherit a physician's practice, but they can inherit a business." Dr. Battle does not treat patients himself, so the Cultura Cosmetic Dermatology and Laser Center in Washington, is considered a business rather than a practice.

Because he offers limited procedures, his staff has become expert in performing them, he said. But when he encounters anything beyond what he is prepared to offer, Dr. Battle refers to a medical dermatologist.

"My medical oath says to do no harm, and that rules all that I do. We are always looking out for the patient's best interest. If I see a suspicious mole or a concerning flare of lupus, I refer. I am not geared to help that person."

 

 

Dr. Battle hasn't completely foresworn either medical or academic work, however. He conducts research at Howard University, Washington, and teaches residents who are interested in cosmetic dermatology.

His business background puts him in a position to offer business advice, and his age, he said, allows him to give personal counsel as well.

"One thing I tell residents is that just because they might generate a lot of revenue with a cosmetic practice doesn't necessarily mean they'll generate a lot of profit. It's also important for people to be true to themselves. I encourage them to look deeply into this and not be blinded by the idea that they'll make tons of money doing cosmetic work. A lot of residents really enjoy the academic side of medicine, and cosmetic dermatology will not bring them that. If academics are your passion, you should not forego that for the temporary dollar."

Dr. Tanzi is on the medical advisory board for Zeltiq. Dr. Cox is a consultant for Medisys and Allergan. Dr. Battle and Dr. Fitch reported having no conflicts of interest.

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Point/Counterpoint: Is Mohs Surgery Being Overutilized?

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Point/Counterpoint: Is Mohs Surgery Being Overutilized?

Yes - Surgeons Are Softening Criteria for Who Gets Mohs.

By David S. Becker, M.D.

The practice of Mohs micrographic surgery is in some cases drifting away from the classic indications that used to make up most of our practice.

There are different published criteria for cases indicated for Mohs surgery, but these often include patients with recurrent or incompletely excised skin cancers, aggressive histology, or poorly defined margins. Other classic indications include tumors larger than 0.4 cm in high-risk H-zone locations, larger than 1 cm elsewhere on the face, or larger than 2 cm on the trunk or extremities.

Some of these listed criteria would not include a 3-mm basal cell carcinoma on the nose or ear, an 8-mm basal cell carcinoma on the cheek or forehead, or a 1.5-cm lesion on the pretibial skin, but I often have had each of these referred to me for Mohs surgery.

What's driving us to soften these traditional indications for Mohs surgery? Patients, referring dermatologists, dermatopathologists, and Mohs surgeons each may play a role.

Patients love Mohs surgery for many reasons. For one, we do a good job. Perhaps they've had previous Mohs surgery with good results or their friends have, or they have looked online and found that Mohs has the best cure rate. Or, they may have had a bad experience with a prior treatment.

It's not uncommon for patients to do research, and then want to play a role in determining their medical care. If they demand Mohs surgery, and I don't think it's indicated, it can lead to a contentious consultation.

One young man with a squamous cell carcinoma on his chest recently told me that he had researched the cure rates of treatments and he wanted Mohs surgery. He was almost certainly correct that if the sole criteria for therapy were best cure rate, Mohs would be the choice.

There are only two downsides to Mohs versus excision in a case like this: One, the patient has to spend more time in the office for Mohs surgery; and two, it is perhaps overutilization of medical resources. Good luck trying to explain that to patients. They don't care about overutilization of resources.

Who else drives this drift toward enhanced Mohs utilization? Referring dermatologists. They may have an interest in maximizing utilization of a Mohs surgeon in their practice, while some dermatologists have truly been burned, that is, had a patient with a metastatic squamous cell carcinoma or difficult recurrences, and they want the greater certitude of cure from Mohs surgery.

Sometimes the referring dermatologist says the patient is a VIP or relative and asks me to make an exception. If you start making exceptions, pretty soon you're seeing a lot of patients who don't necessarily meet the classic criteria for Mohs surgery.

The next set of people who are driving this drift in overutilization is dermatopathologists. We have dermatopathologists being overly cautious and prudent in ways they may not have been 10-15 years ago. Something that might have been diagnosed as actinic keratosis 20 years ago might now be called actinic keratosis with extension to the base, "squamous cell carcinoma cannot be excluded," or superficially invasive squamous cell carcinoma.
Mohs surgeons also drive the drift in utilization. We do it because that's what we like to do, or because we work for someone and we want to do what they tell us to do, or we have a referring dermatologist whom we want to please. And we want to keep our patients happy too.

It may be time to reconceptualize the indications for Mohs surgery. Should patient demand or anxiety be an indication? Should the referring dermatologist's or Mohs surgeon's instincts about a given lesion be an indication? Should any small lesion on the face be an indication?
Finally, who should decide when to do Mohs surgery? Should it be patients? They want some autonomy and to play a role in managing their own care, and are often educated in doing so.

Should it be the referring dermatologist? They understand the history of a given lesion and know the patient and the response to prior therapies.
Should the Mohs surgeon decide? We have the most experience with cutaneous malignancies, and in many cases we're the best suited to decide who needs Mohs and who doesn't.

Or, finally, should it be the government or insurers? I think that because we have allowed this drift in utilization to go forward, that may be who ultimately is deciding.

Dr. Becker is a Mohs surgeon in private practice in New York. He said he has no relevant conflicts of interest. His comments were presented at the American College of Mohs Surgery meeting.

 

 

No -  Mohs Surgery Is Being Properly Utilized.

By Gary Monheit, M.D.

Mohs micrographic surgery is not overutilized, it's increasingly utilized.

A recent study reported a twofold increase in the proportion of Mohs surgery being done in Medicare patients from 2001 to 2006, while the rate of excisions has remained stable. So what's driving this increased utilization of Mohs surgery?

Is it greedy surgeons applying Mohs micrographic surgery to actinic keratoses on the arms and trunk? The few surgeons who are utilizing it inappropriately need to be controlled, but I don't believe this is the main reason for the increased utilization.

In most cases, increased Mohs utilization is appropriate. Mohs is a superior and much more cost-effective modality than excision and it has a greater cure rate, which is now being recognized.

The vision of Dr. Frederic E. Mohs was a change in the treatment of skin cancer. He was tired of seeing recurrences with excision. He realized that if things were accurately mapped out, physicians would have a better understanding of how to treat tumors, spare tissue, and reduce costs.

Brilliantly, it was a merger of surgery and histopathology controlled by one practitioner, the Mohs surgeon. Results of surgical treatment approach 100% the first time.

Should this be done for all nonmelanoma skin cancers at all locations? Should patients be cured the first time rather than risk recurrences? Is this cost effective for most tumors?

Twenty years ago, 50% or more of the Mohs surgeries that I did were on patients with tumors that had undergone two surgical excisions with recurrences that were covered up with flaps. I'm very happy to say that now I'm curing patients with a primary basal cell carcinoma the first time I operate.

We are having a cancer epidemic. The annual incidence of nonmelanoma skin cancer is a staggering 3.5 million, according to a recent study involving epidemiologic databases and the National Cancer Institute (Arch. Dermatol. 2010;146:283-7). And, I think the incidence is much higher.

The same study reported a 4.2% annual growth rate. That would predict a 23% growth rate in Mohs micrographic surgery from 2001 to 2006. Instead, we had a 70% growth rate.

What accounts for this? I believe the high growth rate is driven by what I call the "miracle of Mohs surgery." Five-year recurrence rates after Mohs are 1% for primary basal cell carcinomas, compared with 10% for surgical excision in well-controlled studies, and 4% after Mohs surgery for recurrent basal cell carcinomas, as opposed to 17% for excision.

Studies have found that 18%-32% of facial basal cell carcinomas are incompletely excised and require a second procedure. Repeat excisions create larger defects and worse cosmetic outcomes. Complete re-excisions are challenging after flap repairs. But with Mohs, one procedure does it all.
Studies have shown that Mohs surgery is superior financially because it is more cost effective than traditional excision if you include the costs of re-excision and pathology, and re-repair and treatment of recurrences after excisions.

Patients also are twice as satisfied with Mohs surgery, another study found (Dermatol. Surg. 2009;35:1041-9).

We've got an epidemic of cancer, and we have recognition that Mohs is the best technique for treatment. Patients with tumors that would have been excised and recurred are being referred initially for Mohs surgery. Simple primary lesions that are in the right areas should be treated with Mohs.

Does increased utilization of Mohs surgery translate to greater expense in treating skin cancer? The data show that for primary lesions and recurrences, the cost savings is greater with Mohs surgery. Insurance companies are starting to recognize that, but we can't let insurance companies govern simply by cost.

We really don't know for sure what's driving the increase in Mohs micrographic surgery utilization. However, I do believe that the superiority of the technique, which is becoming more recognized and established, and the epidemic of skin cancer have produced this high rate of utilization.

The growth rate reflects recognition of the unparalleled value of Mohs micrographic surgery as we confront the skin cancer epidemic.

Dr. Monheit is a Mohs surgeon in private practice in Birmingham, Ala., and has directed Mohs fellowship programs for 25 years. He said he has no other relevant conflicts of interest. These remarks were presented at the American College of Mohs Surgery meeting.

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Yes - Surgeons Are Softening Criteria for Who Gets Mohs.

By David S. Becker, M.D.

The practice of Mohs micrographic surgery is in some cases drifting away from the classic indications that used to make up most of our practice.

There are different published criteria for cases indicated for Mohs surgery, but these often include patients with recurrent or incompletely excised skin cancers, aggressive histology, or poorly defined margins. Other classic indications include tumors larger than 0.4 cm in high-risk H-zone locations, larger than 1 cm elsewhere on the face, or larger than 2 cm on the trunk or extremities.

Some of these listed criteria would not include a 3-mm basal cell carcinoma on the nose or ear, an 8-mm basal cell carcinoma on the cheek or forehead, or a 1.5-cm lesion on the pretibial skin, but I often have had each of these referred to me for Mohs surgery.

What's driving us to soften these traditional indications for Mohs surgery? Patients, referring dermatologists, dermatopathologists, and Mohs surgeons each may play a role.

Patients love Mohs surgery for many reasons. For one, we do a good job. Perhaps they've had previous Mohs surgery with good results or their friends have, or they have looked online and found that Mohs has the best cure rate. Or, they may have had a bad experience with a prior treatment.

It's not uncommon for patients to do research, and then want to play a role in determining their medical care. If they demand Mohs surgery, and I don't think it's indicated, it can lead to a contentious consultation.

One young man with a squamous cell carcinoma on his chest recently told me that he had researched the cure rates of treatments and he wanted Mohs surgery. He was almost certainly correct that if the sole criteria for therapy were best cure rate, Mohs would be the choice.

There are only two downsides to Mohs versus excision in a case like this: One, the patient has to spend more time in the office for Mohs surgery; and two, it is perhaps overutilization of medical resources. Good luck trying to explain that to patients. They don't care about overutilization of resources.

Who else drives this drift toward enhanced Mohs utilization? Referring dermatologists. They may have an interest in maximizing utilization of a Mohs surgeon in their practice, while some dermatologists have truly been burned, that is, had a patient with a metastatic squamous cell carcinoma or difficult recurrences, and they want the greater certitude of cure from Mohs surgery.

Sometimes the referring dermatologist says the patient is a VIP or relative and asks me to make an exception. If you start making exceptions, pretty soon you're seeing a lot of patients who don't necessarily meet the classic criteria for Mohs surgery.

The next set of people who are driving this drift in overutilization is dermatopathologists. We have dermatopathologists being overly cautious and prudent in ways they may not have been 10-15 years ago. Something that might have been diagnosed as actinic keratosis 20 years ago might now be called actinic keratosis with extension to the base, "squamous cell carcinoma cannot be excluded," or superficially invasive squamous cell carcinoma.
Mohs surgeons also drive the drift in utilization. We do it because that's what we like to do, or because we work for someone and we want to do what they tell us to do, or we have a referring dermatologist whom we want to please. And we want to keep our patients happy too.

It may be time to reconceptualize the indications for Mohs surgery. Should patient demand or anxiety be an indication? Should the referring dermatologist's or Mohs surgeon's instincts about a given lesion be an indication? Should any small lesion on the face be an indication?
Finally, who should decide when to do Mohs surgery? Should it be patients? They want some autonomy and to play a role in managing their own care, and are often educated in doing so.

Should it be the referring dermatologist? They understand the history of a given lesion and know the patient and the response to prior therapies.
Should the Mohs surgeon decide? We have the most experience with cutaneous malignancies, and in many cases we're the best suited to decide who needs Mohs and who doesn't.

Or, finally, should it be the government or insurers? I think that because we have allowed this drift in utilization to go forward, that may be who ultimately is deciding.

Dr. Becker is a Mohs surgeon in private practice in New York. He said he has no relevant conflicts of interest. His comments were presented at the American College of Mohs Surgery meeting.

 

 

No -  Mohs Surgery Is Being Properly Utilized.

By Gary Monheit, M.D.

Mohs micrographic surgery is not overutilized, it's increasingly utilized.

A recent study reported a twofold increase in the proportion of Mohs surgery being done in Medicare patients from 2001 to 2006, while the rate of excisions has remained stable. So what's driving this increased utilization of Mohs surgery?

Is it greedy surgeons applying Mohs micrographic surgery to actinic keratoses on the arms and trunk? The few surgeons who are utilizing it inappropriately need to be controlled, but I don't believe this is the main reason for the increased utilization.

In most cases, increased Mohs utilization is appropriate. Mohs is a superior and much more cost-effective modality than excision and it has a greater cure rate, which is now being recognized.

The vision of Dr. Frederic E. Mohs was a change in the treatment of skin cancer. He was tired of seeing recurrences with excision. He realized that if things were accurately mapped out, physicians would have a better understanding of how to treat tumors, spare tissue, and reduce costs.

Brilliantly, it was a merger of surgery and histopathology controlled by one practitioner, the Mohs surgeon. Results of surgical treatment approach 100% the first time.

Should this be done for all nonmelanoma skin cancers at all locations? Should patients be cured the first time rather than risk recurrences? Is this cost effective for most tumors?

Twenty years ago, 50% or more of the Mohs surgeries that I did were on patients with tumors that had undergone two surgical excisions with recurrences that were covered up with flaps. I'm very happy to say that now I'm curing patients with a primary basal cell carcinoma the first time I operate.

We are having a cancer epidemic. The annual incidence of nonmelanoma skin cancer is a staggering 3.5 million, according to a recent study involving epidemiologic databases and the National Cancer Institute (Arch. Dermatol. 2010;146:283-7). And, I think the incidence is much higher.

The same study reported a 4.2% annual growth rate. That would predict a 23% growth rate in Mohs micrographic surgery from 2001 to 2006. Instead, we had a 70% growth rate.

What accounts for this? I believe the high growth rate is driven by what I call the "miracle of Mohs surgery." Five-year recurrence rates after Mohs are 1% for primary basal cell carcinomas, compared with 10% for surgical excision in well-controlled studies, and 4% after Mohs surgery for recurrent basal cell carcinomas, as opposed to 17% for excision.

Studies have found that 18%-32% of facial basal cell carcinomas are incompletely excised and require a second procedure. Repeat excisions create larger defects and worse cosmetic outcomes. Complete re-excisions are challenging after flap repairs. But with Mohs, one procedure does it all.
Studies have shown that Mohs surgery is superior financially because it is more cost effective than traditional excision if you include the costs of re-excision and pathology, and re-repair and treatment of recurrences after excisions.

Patients also are twice as satisfied with Mohs surgery, another study found (Dermatol. Surg. 2009;35:1041-9).

We've got an epidemic of cancer, and we have recognition that Mohs is the best technique for treatment. Patients with tumors that would have been excised and recurred are being referred initially for Mohs surgery. Simple primary lesions that are in the right areas should be treated with Mohs.

Does increased utilization of Mohs surgery translate to greater expense in treating skin cancer? The data show that for primary lesions and recurrences, the cost savings is greater with Mohs surgery. Insurance companies are starting to recognize that, but we can't let insurance companies govern simply by cost.

We really don't know for sure what's driving the increase in Mohs micrographic surgery utilization. However, I do believe that the superiority of the technique, which is becoming more recognized and established, and the epidemic of skin cancer have produced this high rate of utilization.

The growth rate reflects recognition of the unparalleled value of Mohs micrographic surgery as we confront the skin cancer epidemic.

Dr. Monheit is a Mohs surgeon in private practice in Birmingham, Ala., and has directed Mohs fellowship programs for 25 years. He said he has no other relevant conflicts of interest. These remarks were presented at the American College of Mohs Surgery meeting.

Yes - Surgeons Are Softening Criteria for Who Gets Mohs.

By David S. Becker, M.D.

The practice of Mohs micrographic surgery is in some cases drifting away from the classic indications that used to make up most of our practice.

There are different published criteria for cases indicated for Mohs surgery, but these often include patients with recurrent or incompletely excised skin cancers, aggressive histology, or poorly defined margins. Other classic indications include tumors larger than 0.4 cm in high-risk H-zone locations, larger than 1 cm elsewhere on the face, or larger than 2 cm on the trunk or extremities.

Some of these listed criteria would not include a 3-mm basal cell carcinoma on the nose or ear, an 8-mm basal cell carcinoma on the cheek or forehead, or a 1.5-cm lesion on the pretibial skin, but I often have had each of these referred to me for Mohs surgery.

What's driving us to soften these traditional indications for Mohs surgery? Patients, referring dermatologists, dermatopathologists, and Mohs surgeons each may play a role.

Patients love Mohs surgery for many reasons. For one, we do a good job. Perhaps they've had previous Mohs surgery with good results or their friends have, or they have looked online and found that Mohs has the best cure rate. Or, they may have had a bad experience with a prior treatment.

It's not uncommon for patients to do research, and then want to play a role in determining their medical care. If they demand Mohs surgery, and I don't think it's indicated, it can lead to a contentious consultation.

One young man with a squamous cell carcinoma on his chest recently told me that he had researched the cure rates of treatments and he wanted Mohs surgery. He was almost certainly correct that if the sole criteria for therapy were best cure rate, Mohs would be the choice.

There are only two downsides to Mohs versus excision in a case like this: One, the patient has to spend more time in the office for Mohs surgery; and two, it is perhaps overutilization of medical resources. Good luck trying to explain that to patients. They don't care about overutilization of resources.

Who else drives this drift toward enhanced Mohs utilization? Referring dermatologists. They may have an interest in maximizing utilization of a Mohs surgeon in their practice, while some dermatologists have truly been burned, that is, had a patient with a metastatic squamous cell carcinoma or difficult recurrences, and they want the greater certitude of cure from Mohs surgery.

Sometimes the referring dermatologist says the patient is a VIP or relative and asks me to make an exception. If you start making exceptions, pretty soon you're seeing a lot of patients who don't necessarily meet the classic criteria for Mohs surgery.

The next set of people who are driving this drift in overutilization is dermatopathologists. We have dermatopathologists being overly cautious and prudent in ways they may not have been 10-15 years ago. Something that might have been diagnosed as actinic keratosis 20 years ago might now be called actinic keratosis with extension to the base, "squamous cell carcinoma cannot be excluded," or superficially invasive squamous cell carcinoma.
Mohs surgeons also drive the drift in utilization. We do it because that's what we like to do, or because we work for someone and we want to do what they tell us to do, or we have a referring dermatologist whom we want to please. And we want to keep our patients happy too.

It may be time to reconceptualize the indications for Mohs surgery. Should patient demand or anxiety be an indication? Should the referring dermatologist's or Mohs surgeon's instincts about a given lesion be an indication? Should any small lesion on the face be an indication?
Finally, who should decide when to do Mohs surgery? Should it be patients? They want some autonomy and to play a role in managing their own care, and are often educated in doing so.

Should it be the referring dermatologist? They understand the history of a given lesion and know the patient and the response to prior therapies.
Should the Mohs surgeon decide? We have the most experience with cutaneous malignancies, and in many cases we're the best suited to decide who needs Mohs and who doesn't.

Or, finally, should it be the government or insurers? I think that because we have allowed this drift in utilization to go forward, that may be who ultimately is deciding.

Dr. Becker is a Mohs surgeon in private practice in New York. He said he has no relevant conflicts of interest. His comments were presented at the American College of Mohs Surgery meeting.

 

 

No -  Mohs Surgery Is Being Properly Utilized.

By Gary Monheit, M.D.

Mohs micrographic surgery is not overutilized, it's increasingly utilized.

A recent study reported a twofold increase in the proportion of Mohs surgery being done in Medicare patients from 2001 to 2006, while the rate of excisions has remained stable. So what's driving this increased utilization of Mohs surgery?

Is it greedy surgeons applying Mohs micrographic surgery to actinic keratoses on the arms and trunk? The few surgeons who are utilizing it inappropriately need to be controlled, but I don't believe this is the main reason for the increased utilization.

In most cases, increased Mohs utilization is appropriate. Mohs is a superior and much more cost-effective modality than excision and it has a greater cure rate, which is now being recognized.

The vision of Dr. Frederic E. Mohs was a change in the treatment of skin cancer. He was tired of seeing recurrences with excision. He realized that if things were accurately mapped out, physicians would have a better understanding of how to treat tumors, spare tissue, and reduce costs.

Brilliantly, it was a merger of surgery and histopathology controlled by one practitioner, the Mohs surgeon. Results of surgical treatment approach 100% the first time.

Should this be done for all nonmelanoma skin cancers at all locations? Should patients be cured the first time rather than risk recurrences? Is this cost effective for most tumors?

Twenty years ago, 50% or more of the Mohs surgeries that I did were on patients with tumors that had undergone two surgical excisions with recurrences that were covered up with flaps. I'm very happy to say that now I'm curing patients with a primary basal cell carcinoma the first time I operate.

We are having a cancer epidemic. The annual incidence of nonmelanoma skin cancer is a staggering 3.5 million, according to a recent study involving epidemiologic databases and the National Cancer Institute (Arch. Dermatol. 2010;146:283-7). And, I think the incidence is much higher.

The same study reported a 4.2% annual growth rate. That would predict a 23% growth rate in Mohs micrographic surgery from 2001 to 2006. Instead, we had a 70% growth rate.

What accounts for this? I believe the high growth rate is driven by what I call the "miracle of Mohs surgery." Five-year recurrence rates after Mohs are 1% for primary basal cell carcinomas, compared with 10% for surgical excision in well-controlled studies, and 4% after Mohs surgery for recurrent basal cell carcinomas, as opposed to 17% for excision.

Studies have found that 18%-32% of facial basal cell carcinomas are incompletely excised and require a second procedure. Repeat excisions create larger defects and worse cosmetic outcomes. Complete re-excisions are challenging after flap repairs. But with Mohs, one procedure does it all.
Studies have shown that Mohs surgery is superior financially because it is more cost effective than traditional excision if you include the costs of re-excision and pathology, and re-repair and treatment of recurrences after excisions.

Patients also are twice as satisfied with Mohs surgery, another study found (Dermatol. Surg. 2009;35:1041-9).

We've got an epidemic of cancer, and we have recognition that Mohs is the best technique for treatment. Patients with tumors that would have been excised and recurred are being referred initially for Mohs surgery. Simple primary lesions that are in the right areas should be treated with Mohs.

Does increased utilization of Mohs surgery translate to greater expense in treating skin cancer? The data show that for primary lesions and recurrences, the cost savings is greater with Mohs surgery. Insurance companies are starting to recognize that, but we can't let insurance companies govern simply by cost.

We really don't know for sure what's driving the increase in Mohs micrographic surgery utilization. However, I do believe that the superiority of the technique, which is becoming more recognized and established, and the epidemic of skin cancer have produced this high rate of utilization.

The growth rate reflects recognition of the unparalleled value of Mohs micrographic surgery as we confront the skin cancer epidemic.

Dr. Monheit is a Mohs surgeon in private practice in Birmingham, Ala., and has directed Mohs fellowship programs for 25 years. He said he has no other relevant conflicts of interest. These remarks were presented at the American College of Mohs Surgery meeting.

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Second Botox Rival Joins Frown Line Market

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On July 21, the Food and Drug Administration approved incobotulinumtoxinA for the temporary improvement in appearance of moderate to severe glabellar lines in adult patients.

Manufactured by Merz Aesthetics and marketed as Xeomin, incobotulinumtoxinA is the third botulinum toxin type A to enter the marketplace, following Botox and Dysport, respectively. It is expected to be available to physicians in the United States in the spring of 2012.

IncobotulinumtoxinA's approval is based on results from two clinical trials conducted at 16 sites in the United States that included 547 healthy adult patients. According to Merz, in both studies, the product significantly improved the appearance of glabellar lines 30 days after the first injection, compared with placebo.

IncobotulinumtoxinA is classified as a pregnancy category C agent and is the only botulinum toxin currently approved in the United States that does not require refrigeration prior to reconstitution.

    Dr. Joel L. Cohen

In an interview, Dr. Joel L. Cohen, one of the trial investigators and director of AboutSkin Dermatology in Denver called incobotulinumtoxinA "more similar than it is different to other products that are on the market, particularly Botox. It’s exciting for botulinum toxin to be in the news again for something very positive in the approval of another product. I think that we should feel comfortable using Xeomin as something that has demonstrated safety and efficacy."

Dr. Christopher Zachary    

Dr. Christopher Zachary, professor and chair of the department of dermatology at the University of California, Irvine, predicted that Xeomin "is going to give Allergan a run for its money. The introduction of this product is likely to be more easily adopted than rival Dysport because one vial of Xeomin contains 100 units of botulinum toxin and can be diluted similarly. Dose for dose, this direct comparison with Botox is going to make staff feel quite comfortable from the get-go. Requiring staff to use different dilutions and maintain correct labeling just adds another element of confusion and might increase the potential for incorrect dosing. Having said this, Dysport remains a premier and very equivalent product and will have its devotees."

According to Merz, use of the product is contraindicated "in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s)." The company also noted that the potency units of incobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products. "Therefore, units of biological activity of Xeomin cannot be compared to or converted into units of any other botulinum toxin products."

The most common adverse reaction was headache, which was reported by 5.4% of patients in the trials.

Xeomin is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy and Spain, under the brand name Bocouture.

Dr. Cohen disclosed that he has been a consultant and clinical trial investigator for Merz, Allergan, and Medicis.

Dr. Zachary disclosed that he has received support and honoraria from Merz, Allergan, and Medicis for various educational courses in recent years.

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On July 21, the Food and Drug Administration approved incobotulinumtoxinA for the temporary improvement in appearance of moderate to severe glabellar lines in adult patients.

Manufactured by Merz Aesthetics and marketed as Xeomin, incobotulinumtoxinA is the third botulinum toxin type A to enter the marketplace, following Botox and Dysport, respectively. It is expected to be available to physicians in the United States in the spring of 2012.

IncobotulinumtoxinA's approval is based on results from two clinical trials conducted at 16 sites in the United States that included 547 healthy adult patients. According to Merz, in both studies, the product significantly improved the appearance of glabellar lines 30 days after the first injection, compared with placebo.

IncobotulinumtoxinA is classified as a pregnancy category C agent and is the only botulinum toxin currently approved in the United States that does not require refrigeration prior to reconstitution.

    Dr. Joel L. Cohen

In an interview, Dr. Joel L. Cohen, one of the trial investigators and director of AboutSkin Dermatology in Denver called incobotulinumtoxinA "more similar than it is different to other products that are on the market, particularly Botox. It’s exciting for botulinum toxin to be in the news again for something very positive in the approval of another product. I think that we should feel comfortable using Xeomin as something that has demonstrated safety and efficacy."

Dr. Christopher Zachary    

Dr. Christopher Zachary, professor and chair of the department of dermatology at the University of California, Irvine, predicted that Xeomin "is going to give Allergan a run for its money. The introduction of this product is likely to be more easily adopted than rival Dysport because one vial of Xeomin contains 100 units of botulinum toxin and can be diluted similarly. Dose for dose, this direct comparison with Botox is going to make staff feel quite comfortable from the get-go. Requiring staff to use different dilutions and maintain correct labeling just adds another element of confusion and might increase the potential for incorrect dosing. Having said this, Dysport remains a premier and very equivalent product and will have its devotees."

According to Merz, use of the product is contraindicated "in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s)." The company also noted that the potency units of incobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products. "Therefore, units of biological activity of Xeomin cannot be compared to or converted into units of any other botulinum toxin products."

The most common adverse reaction was headache, which was reported by 5.4% of patients in the trials.

Xeomin is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy and Spain, under the brand name Bocouture.

Dr. Cohen disclosed that he has been a consultant and clinical trial investigator for Merz, Allergan, and Medicis.

Dr. Zachary disclosed that he has received support and honoraria from Merz, Allergan, and Medicis for various educational courses in recent years.

On July 21, the Food and Drug Administration approved incobotulinumtoxinA for the temporary improvement in appearance of moderate to severe glabellar lines in adult patients.

Manufactured by Merz Aesthetics and marketed as Xeomin, incobotulinumtoxinA is the third botulinum toxin type A to enter the marketplace, following Botox and Dysport, respectively. It is expected to be available to physicians in the United States in the spring of 2012.

IncobotulinumtoxinA's approval is based on results from two clinical trials conducted at 16 sites in the United States that included 547 healthy adult patients. According to Merz, in both studies, the product significantly improved the appearance of glabellar lines 30 days after the first injection, compared with placebo.

IncobotulinumtoxinA is classified as a pregnancy category C agent and is the only botulinum toxin currently approved in the United States that does not require refrigeration prior to reconstitution.

    Dr. Joel L. Cohen

In an interview, Dr. Joel L. Cohen, one of the trial investigators and director of AboutSkin Dermatology in Denver called incobotulinumtoxinA "more similar than it is different to other products that are on the market, particularly Botox. It’s exciting for botulinum toxin to be in the news again for something very positive in the approval of another product. I think that we should feel comfortable using Xeomin as something that has demonstrated safety and efficacy."

Dr. Christopher Zachary    

Dr. Christopher Zachary, professor and chair of the department of dermatology at the University of California, Irvine, predicted that Xeomin "is going to give Allergan a run for its money. The introduction of this product is likely to be more easily adopted than rival Dysport because one vial of Xeomin contains 100 units of botulinum toxin and can be diluted similarly. Dose for dose, this direct comparison with Botox is going to make staff feel quite comfortable from the get-go. Requiring staff to use different dilutions and maintain correct labeling just adds another element of confusion and might increase the potential for incorrect dosing. Having said this, Dysport remains a premier and very equivalent product and will have its devotees."

According to Merz, use of the product is contraindicated "in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s)." The company also noted that the potency units of incobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products. "Therefore, units of biological activity of Xeomin cannot be compared to or converted into units of any other botulinum toxin products."

The most common adverse reaction was headache, which was reported by 5.4% of patients in the trials.

Xeomin is approved for the temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy and Spain, under the brand name Bocouture.

Dr. Cohen disclosed that he has been a consultant and clinical trial investigator for Merz, Allergan, and Medicis.

Dr. Zachary disclosed that he has received support and honoraria from Merz, Allergan, and Medicis for various educational courses in recent years.

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Bone Density May Affect Rejuvenation Efforts

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Skin tightening may minimize wrinkles, but it won't compensate for underlying structural changes.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm2, and for the women were 1.23, 1.24, and 1.08 g/cm2. For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm2, and for the women they were 1.75, 1.55, and 1.50 g/cm2. For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm2, and for the female subjects they were 1.52, 1.32, and 1.18 g/cm2.

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

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Skin tightening may minimize wrinkles, but it won't compensate for underlying structural changes.
Skin tightening may minimize wrinkles, but it won't compensate for underlying structural changes.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm2, and for the women were 1.23, 1.24, and 1.08 g/cm2. For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm2, and for the women they were 1.75, 1.55, and 1.50 g/cm2. For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm2, and for the female subjects they were 1.52, 1.32, and 1.18 g/cm2.

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm2, and for the women were 1.23, 1.24, and 1.08 g/cm2. For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm2, and for the women they were 1.75, 1.55, and 1.50 g/cm2. For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm2, and for the female subjects they were 1.52, 1.32, and 1.18 g/cm2.

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY

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Major Finding: The densities of the maxilla in women aged 20-40 years, 40-60 years, and older than 60 years were 1.75, 1.55, and 1.50 g/cm2, respectively. Similar decreases in density were seen in other facial bone sites in both women and men.

Data Source: Study comparing axial and facial bone density among different age groupings of 30 female and 30 male subjects.

Disclosures: Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

Tretinoin, Isotretinoin Found Equally Effective for Photoaging

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SEOUL, SOUTH KOREA – Low-dose oral isotretinoin and alternate-day tretinoin proved similarly effective for treatment of photoaging in a prospective randomized trial.

Treatment of photoaged skin is an off-label application for isotretinoin, but there have been a number of published favorable case series (J. Eur. Acad. Dermatol. Venereol. 2009;23:115-23).

Some dermatologists are prescribing it in more severe cases where teratogenicity is a nonissue. So Dr. Edileia Bagatin decided to put the potent oral retinoid to the test in a randomized comparison with tretinoin (Renova), a topical retinoid that does have a regulatory indication for photoaging.

The result of the 12-month study was a draw in terms of efficacy. The two treatment groups showed similar improvements in photoaging based upon blinded dermatologic evaluations, patient self-ratings, quality of life scores, and histologic findings.

And because the topical retinoid doesn't come with the baggage for which isotretinoin is notorious – including dyslipidemia, birth defects, liver dysfunction, depression, and inflammatory bowel disease – tretinoin has the clear advantage in most situations, said Dr. Bagatin at the World Congress of Dermatology.

The trial involved 22 patients, aged 50-75 years, with moderate to advanced photoaging. Nine of 11 subjects in each treatment arm were smokers.

Patients were assigned to either 20 mg/day of isotretinoin for 6 months followed by 0.05% tretinoin cream applied every other day for 6 months, or to alternate-day tretinoin for the full 12 months. All patients were instructed to use a moisturizing sunscreen twice daily.

The number of actinic keratoses on the face was reduced to a similar extent via both therapies: by an average of 74% after 6 months and 54% after 12 months. The number of AKs on the forearms dropped by an average of 42% with either therapy after 6 months, and by 61% after 12 months, according to Dr. Bagatin, of the Federal University of Sao Paulo (Brazil).

The patients themselves rated their wrinkles, skin elasticity, actinic keratoses, and freckles as significantly improved at both 6 and 12 months, with no significant difference between treatment arms. Median Dermatology Life Quality Index scores showed significant improvement over time, again with no difference between the two groups.

On histology, both groups displayed reductions in corneal layer thickness and elastosis, along with increased epidermal thickness; these changes were greater with time. There was also a significant reduction in p53 expression and an increase in collagen I, with both changes being greater at 12 months than 6 months.

The study was funded by the Sao Paulo State Research Foundation. Dr. Bagatin reported having no financial conflicts.

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SEOUL, SOUTH KOREA – Low-dose oral isotretinoin and alternate-day tretinoin proved similarly effective for treatment of photoaging in a prospective randomized trial.

Treatment of photoaged skin is an off-label application for isotretinoin, but there have been a number of published favorable case series (J. Eur. Acad. Dermatol. Venereol. 2009;23:115-23).

Some dermatologists are prescribing it in more severe cases where teratogenicity is a nonissue. So Dr. Edileia Bagatin decided to put the potent oral retinoid to the test in a randomized comparison with tretinoin (Renova), a topical retinoid that does have a regulatory indication for photoaging.

The result of the 12-month study was a draw in terms of efficacy. The two treatment groups showed similar improvements in photoaging based upon blinded dermatologic evaluations, patient self-ratings, quality of life scores, and histologic findings.

And because the topical retinoid doesn't come with the baggage for which isotretinoin is notorious – including dyslipidemia, birth defects, liver dysfunction, depression, and inflammatory bowel disease – tretinoin has the clear advantage in most situations, said Dr. Bagatin at the World Congress of Dermatology.

The trial involved 22 patients, aged 50-75 years, with moderate to advanced photoaging. Nine of 11 subjects in each treatment arm were smokers.

Patients were assigned to either 20 mg/day of isotretinoin for 6 months followed by 0.05% tretinoin cream applied every other day for 6 months, or to alternate-day tretinoin for the full 12 months. All patients were instructed to use a moisturizing sunscreen twice daily.

The number of actinic keratoses on the face was reduced to a similar extent via both therapies: by an average of 74% after 6 months and 54% after 12 months. The number of AKs on the forearms dropped by an average of 42% with either therapy after 6 months, and by 61% after 12 months, according to Dr. Bagatin, of the Federal University of Sao Paulo (Brazil).

The patients themselves rated their wrinkles, skin elasticity, actinic keratoses, and freckles as significantly improved at both 6 and 12 months, with no significant difference between treatment arms. Median Dermatology Life Quality Index scores showed significant improvement over time, again with no difference between the two groups.

On histology, both groups displayed reductions in corneal layer thickness and elastosis, along with increased epidermal thickness; these changes were greater with time. There was also a significant reduction in p53 expression and an increase in collagen I, with both changes being greater at 12 months than 6 months.

The study was funded by the Sao Paulo State Research Foundation. Dr. Bagatin reported having no financial conflicts.

SEOUL, SOUTH KOREA – Low-dose oral isotretinoin and alternate-day tretinoin proved similarly effective for treatment of photoaging in a prospective randomized trial.

Treatment of photoaged skin is an off-label application for isotretinoin, but there have been a number of published favorable case series (J. Eur. Acad. Dermatol. Venereol. 2009;23:115-23).

Some dermatologists are prescribing it in more severe cases where teratogenicity is a nonissue. So Dr. Edileia Bagatin decided to put the potent oral retinoid to the test in a randomized comparison with tretinoin (Renova), a topical retinoid that does have a regulatory indication for photoaging.

The result of the 12-month study was a draw in terms of efficacy. The two treatment groups showed similar improvements in photoaging based upon blinded dermatologic evaluations, patient self-ratings, quality of life scores, and histologic findings.

And because the topical retinoid doesn't come with the baggage for which isotretinoin is notorious – including dyslipidemia, birth defects, liver dysfunction, depression, and inflammatory bowel disease – tretinoin has the clear advantage in most situations, said Dr. Bagatin at the World Congress of Dermatology.

The trial involved 22 patients, aged 50-75 years, with moderate to advanced photoaging. Nine of 11 subjects in each treatment arm were smokers.

Patients were assigned to either 20 mg/day of isotretinoin for 6 months followed by 0.05% tretinoin cream applied every other day for 6 months, or to alternate-day tretinoin for the full 12 months. All patients were instructed to use a moisturizing sunscreen twice daily.

The number of actinic keratoses on the face was reduced to a similar extent via both therapies: by an average of 74% after 6 months and 54% after 12 months. The number of AKs on the forearms dropped by an average of 42% with either therapy after 6 months, and by 61% after 12 months, according to Dr. Bagatin, of the Federal University of Sao Paulo (Brazil).

The patients themselves rated their wrinkles, skin elasticity, actinic keratoses, and freckles as significantly improved at both 6 and 12 months, with no significant difference between treatment arms. Median Dermatology Life Quality Index scores showed significant improvement over time, again with no difference between the two groups.

On histology, both groups displayed reductions in corneal layer thickness and elastosis, along with increased epidermal thickness; these changes were greater with time. There was also a significant reduction in p53 expression and an increase in collagen I, with both changes being greater at 12 months than 6 months.

The study was funded by the Sao Paulo State Research Foundation. Dr. Bagatin reported having no financial conflicts.

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Major Finding: Oral isotretinoin and topical tretinoin both reduced facial actinic keratoses by 74% after 6 months and 54% after 12 months.

Data Source: A 1-year randomized trial comparing the efficacy of low-dose oral isotretinoin to alternate-day tretinoin in 22 patients with photoaging.

Disclosures: The study was funded by the Sao Paulo State Research Foundation. Dr. Bagatin reported having no financial conflicts.

Rosa Damascena

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Research is finding intriguing properties of the flower that have potential for topical dermatologic products.

There is more to Rosa damascena than its gorgeous flowers and lovely scent. Research on this cultivar is finding some intriguing properties that have potential for topical dermatologic products.

Rosa damascena, also known as the Damask Rose and Rose of Castile, is a rose hybrid the flowers of which have been used for rose oil in perfume and for rosewater.

It originates in the Middle East (the name is based on Damascus, Syria), but it is now only a cultivated plant and no longer found in the wild.

Bulgaria, Turkey, France, and India are the largest producers of rose oil. Rosewater has been used for centuries in religious rites and for physical, emotional, and spiritual purposes or healing. Thriving rosewater industries are found in Bulgaria and France.

In addition to its uses in the perfumery industry, R. damascena is also used for culinary purposes in several global cuisines. Geraniol, which exhibits potent antiseptic activity (seven times that of phenol), is the main constituent of several essential oils and is found in R. damascena (Hoffmann D., Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester, Vt.: Healing Arts Press, 2003, p. 64).

Photo: Courtesy Wikimedia Commons/Kurt Stüber/Creative Commons License
    Rosa damascena, from which rosewater and roseoil products are derived, has a long history of pharmaceutical use but scientific research on its medical properties began in the 1970s. 

Some of the earliest work to indicate the potential health and dermatologic benefits of R. damascena dates to the late 1970s.

Investigators isolated a strain of cultured cells of the plant that displayed strong resistance to UV radiation (254 nm) and generated a greater amount of polyphenols (primarily flavonoids) during the latter stages of culture growth. They found that this UV resistance was associated with increased polyphenolic production (Plant Physiol. 1979;64:936-41).

Flavonoids are the most prevalent and frequently studied polyphenols, which are the most abundant source of antioxidants in the human diet (Biomed. Pap. Med. Fac. Univ. Palacky Olomouc Czech Repub. 2003;147:137-45; J. Nutr. 2000;130 (8S Suppl):2073S-85S; Annu. Rev. Nutr. 2002;22:19-34; Pharmacol. Ther. 2001;90:157-77; Free Radic. Biol. Med. 2001;30:1213-22).

Antimicrobial Properties

In 2002, R. damascena was among eight essential oils studied for composition and antimicrobial characteristics. The antibacterial activities of the aromatic extracts were ascertained by disk diffusion testing. Among the standard test bacterial strains Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, R. damascena showed antimicrobial activity against S. aureus (Arch. Pharm. Res. 2002;25:860-4).

Recent work has provided additional evidence of its antibacterial activity. In 2010, investigators tested 10 essential oils for antibacterial activity against Propionibacterium acnes as well as in vitro toxicology against three human cancer cell lines. Among the essential oils tested (which included mint, ginger, lemon, grapefruit, jasmine, lavender, chamomile, thyme, rose, and cinnamon) thyme, cinnamon, and rose were found to display the greatest antibacterial potency against P. acnes. Overall, the cytotoxicity of the essential oils was strongest against human prostate carcinoma cells (PC-3), as opposed to human lung carcinoma (A549) and human breast cancer (MCF-7) cells. Thyme was found to be the most cytotoxic to the cancer cell lines (Molecules 2010;15:3200-10).

UV Protection

In 2003, investigators assessed various extracts of R. damascena for its capacity as an antisolar agent in absorbing UV. The presence of flavonoids as the primary constituents of the extracts was verified before investigators identified the UV absorption spectra, with all three extracts found to be effective in absorbing UV in the 200- to 400-nm range. Next, the team incorporated the extracts into oil-in-water creams at 5% and 8% concentrations. The hydroalcoholic extract provided the highest sun protection factor (SPF), but the cream containing 5% ether extract rendered the most satisfactory appearance and stability. The authors ascribed the UV absorption ability of the extracts to the flavonoid constituents and noted that other synthetic antisolar compounds might be added to R. damascena extracts to enhance overall product efficacy (Int. J. Cosmet. Sci. 2003;25:259-65).

Antioxidant Properties

In 2005, Schiber et al. extracted and characterized flavonol glycosides from R. damascena petals following industrial distillation for essential oil recovery. After analyzing 22 constituents, kaempferol and quercetin were the only flavonoids (specifically, flavonols) detected, with kaempferol compounds accounting for 80% of the compounds measured. In noting the high flavonol content (approximately 16 g/kg in dry weight), the researchers concluded that R. damascena represents a promising source of natural antioxidants (Z. Naturforsch. C. 2005;60:379-84).

In a late 2010 study using a reversed-phase high-performance liquid chromatographic (RP-HPLC) method to simultaneously measure the flavonols, flavones, and phenolic acids as important constituents in various fruits, vegetables, and medicinal plants, R. damascena was identified as one of the species, along with Solidago virgaurea, Ginkgo biloba, and Camellia sinensis (the source of green tea), as having the highest flavonoid content (J. Agric. Food. Chem. 2010 Oct 4. [Epub ahead of print]).

 

 

Notably, G. biloba contains quercetin, one of the most abundant natural flavonoids, as well as other flavonoids such as kaempferol, sciadopitysin, ginkgetin, and isoginkgetin with demonstrated antioxidant and anti-inflammatory activity (Clin. Exp. Dermatol. 2001;26:536-9; Radic. Biol. Med. 1998;25:196-200).

Also in late 2010, investigators assessed the antioxidant activity of plants typically used in Unani medicine, of which the 10 displaying the most promising effects, including R. damascena, were identified for additional analysis. The total phenolic, flavonoid, and ascorbic acid contents were ascertained from methanol (50%) extract preparations of all 10 species and researchers also evaluated the in vitro scavenging of reactive oxygen and nitrogen species and the ability of the plant extracts to prevent oxidative DNA harm. R. damascena was among seven of the 10 extracts to exhibit moderate antioxidant activity and one of three species found to potentially have significant preventive activity against oxidative DNA damage as well as antioxidant activity. The investigators concluded that R. damascena, C. icosandra, and C. scariosus, all of which are commonly used in Unani medicine (practiced in South Asia and founded on traditional Graeco-Arabic medicine) and reportedly deliver substantial benefits in the treatment of various human disorders, are potentially useful as natural antioxidants in pharmaceutical products (BMC Complement. Altern. Med. 2010;16:10-77).

A year earlier, investigators examined the phenolic content as well as the antioxidant and antibacterial activities of R. damascena flower extracts absolute, essential oil, and hydrosol. The major constituents of rose essential oil and hydrosol (great than 55%) were found to be citrenellol and geraniol, with phenylethyl alcohol (78.83%) identified as the primary component of rose absolute. The levels of key antioxidants (i.e, beta carotene, tocopherol, and gamma tocopherol) were found to be higher in rose absolute as compared to hydrosol and rose oil. High levels of phenolics were noted in rose absolute and the essential oil, which exhibited potent antibacterial activity against E. coli, P. aeruginosa, Bacillus subtilis, S. aureus, Chromobacterium violaceum, and Erwinia carotovora (Curr. Microbiol. 2009;59:554-8). Of note, hydrosols, also referred to as floral waters, flower waters, hydroflorates, or distillates, are derived from steam distilling plant materials.

Relaxing Properties

In a recent study on the relaxing effects of rose oil administered by transdermal absorption, 40 healthy volunteers were assessed based on autonomic parameters (i.e., blood pressure, breathing rate, blood oxygen saturation, pulse rate, and skin temperature) as well as self-report after receiving rose oil or placebo. Olfactory stimulation was prevented through the use of breathing masks. Significant reductions in systolic blood pressure, breathing rate, and blood saturation were observed, compared to placebo. The rose oil group also self-reported as calmer, more relaxed, and less alert. The author suggested that this small study lends support for the use of rose oil in aromatherapy for the relief of stress and depression (Nat. Prod. Commun. 2009;4:291-6).

Conclusion

The data that exist on R. damascena are interesting but hardly overwhelming. Much more research is necessary to determine the potential efficacy of this botanical in dermatologic products. The current evidence does offer promise though, and further investigation is clearly warranted to determine the full range of activity offered by R. damascena and how well the antioxidant and antibacterial activities of this herb can be harnessed in topical products.

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Research is finding intriguing properties of the flower that have potential for topical dermatologic products.
Research is finding intriguing properties of the flower that have potential for topical dermatologic products.

There is more to Rosa damascena than its gorgeous flowers and lovely scent. Research on this cultivar is finding some intriguing properties that have potential for topical dermatologic products.

Rosa damascena, also known as the Damask Rose and Rose of Castile, is a rose hybrid the flowers of which have been used for rose oil in perfume and for rosewater.

It originates in the Middle East (the name is based on Damascus, Syria), but it is now only a cultivated plant and no longer found in the wild.

Bulgaria, Turkey, France, and India are the largest producers of rose oil. Rosewater has been used for centuries in religious rites and for physical, emotional, and spiritual purposes or healing. Thriving rosewater industries are found in Bulgaria and France.

In addition to its uses in the perfumery industry, R. damascena is also used for culinary purposes in several global cuisines. Geraniol, which exhibits potent antiseptic activity (seven times that of phenol), is the main constituent of several essential oils and is found in R. damascena (Hoffmann D., Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester, Vt.: Healing Arts Press, 2003, p. 64).

Photo: Courtesy Wikimedia Commons/Kurt Stüber/Creative Commons License
    Rosa damascena, from which rosewater and roseoil products are derived, has a long history of pharmaceutical use but scientific research on its medical properties began in the 1970s. 

Some of the earliest work to indicate the potential health and dermatologic benefits of R. damascena dates to the late 1970s.

Investigators isolated a strain of cultured cells of the plant that displayed strong resistance to UV radiation (254 nm) and generated a greater amount of polyphenols (primarily flavonoids) during the latter stages of culture growth. They found that this UV resistance was associated with increased polyphenolic production (Plant Physiol. 1979;64:936-41).

Flavonoids are the most prevalent and frequently studied polyphenols, which are the most abundant source of antioxidants in the human diet (Biomed. Pap. Med. Fac. Univ. Palacky Olomouc Czech Repub. 2003;147:137-45; J. Nutr. 2000;130 (8S Suppl):2073S-85S; Annu. Rev. Nutr. 2002;22:19-34; Pharmacol. Ther. 2001;90:157-77; Free Radic. Biol. Med. 2001;30:1213-22).

Antimicrobial Properties

In 2002, R. damascena was among eight essential oils studied for composition and antimicrobial characteristics. The antibacterial activities of the aromatic extracts were ascertained by disk diffusion testing. Among the standard test bacterial strains Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, R. damascena showed antimicrobial activity against S. aureus (Arch. Pharm. Res. 2002;25:860-4).

Recent work has provided additional evidence of its antibacterial activity. In 2010, investigators tested 10 essential oils for antibacterial activity against Propionibacterium acnes as well as in vitro toxicology against three human cancer cell lines. Among the essential oils tested (which included mint, ginger, lemon, grapefruit, jasmine, lavender, chamomile, thyme, rose, and cinnamon) thyme, cinnamon, and rose were found to display the greatest antibacterial potency against P. acnes. Overall, the cytotoxicity of the essential oils was strongest against human prostate carcinoma cells (PC-3), as opposed to human lung carcinoma (A549) and human breast cancer (MCF-7) cells. Thyme was found to be the most cytotoxic to the cancer cell lines (Molecules 2010;15:3200-10).

UV Protection

In 2003, investigators assessed various extracts of R. damascena for its capacity as an antisolar agent in absorbing UV. The presence of flavonoids as the primary constituents of the extracts was verified before investigators identified the UV absorption spectra, with all three extracts found to be effective in absorbing UV in the 200- to 400-nm range. Next, the team incorporated the extracts into oil-in-water creams at 5% and 8% concentrations. The hydroalcoholic extract provided the highest sun protection factor (SPF), but the cream containing 5% ether extract rendered the most satisfactory appearance and stability. The authors ascribed the UV absorption ability of the extracts to the flavonoid constituents and noted that other synthetic antisolar compounds might be added to R. damascena extracts to enhance overall product efficacy (Int. J. Cosmet. Sci. 2003;25:259-65).

Antioxidant Properties

In 2005, Schiber et al. extracted and characterized flavonol glycosides from R. damascena petals following industrial distillation for essential oil recovery. After analyzing 22 constituents, kaempferol and quercetin were the only flavonoids (specifically, flavonols) detected, with kaempferol compounds accounting for 80% of the compounds measured. In noting the high flavonol content (approximately 16 g/kg in dry weight), the researchers concluded that R. damascena represents a promising source of natural antioxidants (Z. Naturforsch. C. 2005;60:379-84).

In a late 2010 study using a reversed-phase high-performance liquid chromatographic (RP-HPLC) method to simultaneously measure the flavonols, flavones, and phenolic acids as important constituents in various fruits, vegetables, and medicinal plants, R. damascena was identified as one of the species, along with Solidago virgaurea, Ginkgo biloba, and Camellia sinensis (the source of green tea), as having the highest flavonoid content (J. Agric. Food. Chem. 2010 Oct 4. [Epub ahead of print]).

 

 

Notably, G. biloba contains quercetin, one of the most abundant natural flavonoids, as well as other flavonoids such as kaempferol, sciadopitysin, ginkgetin, and isoginkgetin with demonstrated antioxidant and anti-inflammatory activity (Clin. Exp. Dermatol. 2001;26:536-9; Radic. Biol. Med. 1998;25:196-200).

Also in late 2010, investigators assessed the antioxidant activity of plants typically used in Unani medicine, of which the 10 displaying the most promising effects, including R. damascena, were identified for additional analysis. The total phenolic, flavonoid, and ascorbic acid contents were ascertained from methanol (50%) extract preparations of all 10 species and researchers also evaluated the in vitro scavenging of reactive oxygen and nitrogen species and the ability of the plant extracts to prevent oxidative DNA harm. R. damascena was among seven of the 10 extracts to exhibit moderate antioxidant activity and one of three species found to potentially have significant preventive activity against oxidative DNA damage as well as antioxidant activity. The investigators concluded that R. damascena, C. icosandra, and C. scariosus, all of which are commonly used in Unani medicine (practiced in South Asia and founded on traditional Graeco-Arabic medicine) and reportedly deliver substantial benefits in the treatment of various human disorders, are potentially useful as natural antioxidants in pharmaceutical products (BMC Complement. Altern. Med. 2010;16:10-77).

A year earlier, investigators examined the phenolic content as well as the antioxidant and antibacterial activities of R. damascena flower extracts absolute, essential oil, and hydrosol. The major constituents of rose essential oil and hydrosol (great than 55%) were found to be citrenellol and geraniol, with phenylethyl alcohol (78.83%) identified as the primary component of rose absolute. The levels of key antioxidants (i.e, beta carotene, tocopherol, and gamma tocopherol) were found to be higher in rose absolute as compared to hydrosol and rose oil. High levels of phenolics were noted in rose absolute and the essential oil, which exhibited potent antibacterial activity against E. coli, P. aeruginosa, Bacillus subtilis, S. aureus, Chromobacterium violaceum, and Erwinia carotovora (Curr. Microbiol. 2009;59:554-8). Of note, hydrosols, also referred to as floral waters, flower waters, hydroflorates, or distillates, are derived from steam distilling plant materials.

Relaxing Properties

In a recent study on the relaxing effects of rose oil administered by transdermal absorption, 40 healthy volunteers were assessed based on autonomic parameters (i.e., blood pressure, breathing rate, blood oxygen saturation, pulse rate, and skin temperature) as well as self-report after receiving rose oil or placebo. Olfactory stimulation was prevented through the use of breathing masks. Significant reductions in systolic blood pressure, breathing rate, and blood saturation were observed, compared to placebo. The rose oil group also self-reported as calmer, more relaxed, and less alert. The author suggested that this small study lends support for the use of rose oil in aromatherapy for the relief of stress and depression (Nat. Prod. Commun. 2009;4:291-6).

Conclusion

The data that exist on R. damascena are interesting but hardly overwhelming. Much more research is necessary to determine the potential efficacy of this botanical in dermatologic products. The current evidence does offer promise though, and further investigation is clearly warranted to determine the full range of activity offered by R. damascena and how well the antioxidant and antibacterial activities of this herb can be harnessed in topical products.

There is more to Rosa damascena than its gorgeous flowers and lovely scent. Research on this cultivar is finding some intriguing properties that have potential for topical dermatologic products.

Rosa damascena, also known as the Damask Rose and Rose of Castile, is a rose hybrid the flowers of which have been used for rose oil in perfume and for rosewater.

It originates in the Middle East (the name is based on Damascus, Syria), but it is now only a cultivated plant and no longer found in the wild.

Bulgaria, Turkey, France, and India are the largest producers of rose oil. Rosewater has been used for centuries in religious rites and for physical, emotional, and spiritual purposes or healing. Thriving rosewater industries are found in Bulgaria and France.

In addition to its uses in the perfumery industry, R. damascena is also used for culinary purposes in several global cuisines. Geraniol, which exhibits potent antiseptic activity (seven times that of phenol), is the main constituent of several essential oils and is found in R. damascena (Hoffmann D., Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester, Vt.: Healing Arts Press, 2003, p. 64).

Photo: Courtesy Wikimedia Commons/Kurt Stüber/Creative Commons License
    Rosa damascena, from which rosewater and roseoil products are derived, has a long history of pharmaceutical use but scientific research on its medical properties began in the 1970s. 

Some of the earliest work to indicate the potential health and dermatologic benefits of R. damascena dates to the late 1970s.

Investigators isolated a strain of cultured cells of the plant that displayed strong resistance to UV radiation (254 nm) and generated a greater amount of polyphenols (primarily flavonoids) during the latter stages of culture growth. They found that this UV resistance was associated with increased polyphenolic production (Plant Physiol. 1979;64:936-41).

Flavonoids are the most prevalent and frequently studied polyphenols, which are the most abundant source of antioxidants in the human diet (Biomed. Pap. Med. Fac. Univ. Palacky Olomouc Czech Repub. 2003;147:137-45; J. Nutr. 2000;130 (8S Suppl):2073S-85S; Annu. Rev. Nutr. 2002;22:19-34; Pharmacol. Ther. 2001;90:157-77; Free Radic. Biol. Med. 2001;30:1213-22).

Antimicrobial Properties

In 2002, R. damascena was among eight essential oils studied for composition and antimicrobial characteristics. The antibacterial activities of the aromatic extracts were ascertained by disk diffusion testing. Among the standard test bacterial strains Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa, R. damascena showed antimicrobial activity against S. aureus (Arch. Pharm. Res. 2002;25:860-4).

Recent work has provided additional evidence of its antibacterial activity. In 2010, investigators tested 10 essential oils for antibacterial activity against Propionibacterium acnes as well as in vitro toxicology against three human cancer cell lines. Among the essential oils tested (which included mint, ginger, lemon, grapefruit, jasmine, lavender, chamomile, thyme, rose, and cinnamon) thyme, cinnamon, and rose were found to display the greatest antibacterial potency against P. acnes. Overall, the cytotoxicity of the essential oils was strongest against human prostate carcinoma cells (PC-3), as opposed to human lung carcinoma (A549) and human breast cancer (MCF-7) cells. Thyme was found to be the most cytotoxic to the cancer cell lines (Molecules 2010;15:3200-10).

UV Protection

In 2003, investigators assessed various extracts of R. damascena for its capacity as an antisolar agent in absorbing UV. The presence of flavonoids as the primary constituents of the extracts was verified before investigators identified the UV absorption spectra, with all three extracts found to be effective in absorbing UV in the 200- to 400-nm range. Next, the team incorporated the extracts into oil-in-water creams at 5% and 8% concentrations. The hydroalcoholic extract provided the highest sun protection factor (SPF), but the cream containing 5% ether extract rendered the most satisfactory appearance and stability. The authors ascribed the UV absorption ability of the extracts to the flavonoid constituents and noted that other synthetic antisolar compounds might be added to R. damascena extracts to enhance overall product efficacy (Int. J. Cosmet. Sci. 2003;25:259-65).

Antioxidant Properties

In 2005, Schiber et al. extracted and characterized flavonol glycosides from R. damascena petals following industrial distillation for essential oil recovery. After analyzing 22 constituents, kaempferol and quercetin were the only flavonoids (specifically, flavonols) detected, with kaempferol compounds accounting for 80% of the compounds measured. In noting the high flavonol content (approximately 16 g/kg in dry weight), the researchers concluded that R. damascena represents a promising source of natural antioxidants (Z. Naturforsch. C. 2005;60:379-84).

In a late 2010 study using a reversed-phase high-performance liquid chromatographic (RP-HPLC) method to simultaneously measure the flavonols, flavones, and phenolic acids as important constituents in various fruits, vegetables, and medicinal plants, R. damascena was identified as one of the species, along with Solidago virgaurea, Ginkgo biloba, and Camellia sinensis (the source of green tea), as having the highest flavonoid content (J. Agric. Food. Chem. 2010 Oct 4. [Epub ahead of print]).

 

 

Notably, G. biloba contains quercetin, one of the most abundant natural flavonoids, as well as other flavonoids such as kaempferol, sciadopitysin, ginkgetin, and isoginkgetin with demonstrated antioxidant and anti-inflammatory activity (Clin. Exp. Dermatol. 2001;26:536-9; Radic. Biol. Med. 1998;25:196-200).

Also in late 2010, investigators assessed the antioxidant activity of plants typically used in Unani medicine, of which the 10 displaying the most promising effects, including R. damascena, were identified for additional analysis. The total phenolic, flavonoid, and ascorbic acid contents were ascertained from methanol (50%) extract preparations of all 10 species and researchers also evaluated the in vitro scavenging of reactive oxygen and nitrogen species and the ability of the plant extracts to prevent oxidative DNA harm. R. damascena was among seven of the 10 extracts to exhibit moderate antioxidant activity and one of three species found to potentially have significant preventive activity against oxidative DNA damage as well as antioxidant activity. The investigators concluded that R. damascena, C. icosandra, and C. scariosus, all of which are commonly used in Unani medicine (practiced in South Asia and founded on traditional Graeco-Arabic medicine) and reportedly deliver substantial benefits in the treatment of various human disorders, are potentially useful as natural antioxidants in pharmaceutical products (BMC Complement. Altern. Med. 2010;16:10-77).

A year earlier, investigators examined the phenolic content as well as the antioxidant and antibacterial activities of R. damascena flower extracts absolute, essential oil, and hydrosol. The major constituents of rose essential oil and hydrosol (great than 55%) were found to be citrenellol and geraniol, with phenylethyl alcohol (78.83%) identified as the primary component of rose absolute. The levels of key antioxidants (i.e, beta carotene, tocopherol, and gamma tocopherol) were found to be higher in rose absolute as compared to hydrosol and rose oil. High levels of phenolics were noted in rose absolute and the essential oil, which exhibited potent antibacterial activity against E. coli, P. aeruginosa, Bacillus subtilis, S. aureus, Chromobacterium violaceum, and Erwinia carotovora (Curr. Microbiol. 2009;59:554-8). Of note, hydrosols, also referred to as floral waters, flower waters, hydroflorates, or distillates, are derived from steam distilling plant materials.

Relaxing Properties

In a recent study on the relaxing effects of rose oil administered by transdermal absorption, 40 healthy volunteers were assessed based on autonomic parameters (i.e., blood pressure, breathing rate, blood oxygen saturation, pulse rate, and skin temperature) as well as self-report after receiving rose oil or placebo. Olfactory stimulation was prevented through the use of breathing masks. Significant reductions in systolic blood pressure, breathing rate, and blood saturation were observed, compared to placebo. The rose oil group also self-reported as calmer, more relaxed, and less alert. The author suggested that this small study lends support for the use of rose oil in aromatherapy for the relief of stress and depression (Nat. Prod. Commun. 2009;4:291-6).

Conclusion

The data that exist on R. damascena are interesting but hardly overwhelming. Much more research is necessary to determine the potential efficacy of this botanical in dermatologic products. The current evidence does offer promise though, and further investigation is clearly warranted to determine the full range of activity offered by R. damascena and how well the antioxidant and antibacterial activities of this herb can be harnessed in topical products.

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Scar Prevention 'Band-Aid' Shows Early Promise

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DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

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Comparing scars after 8 months.

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

    Geoffrey C. Gurtner

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

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DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

©Neodyne Biosciences, Inc
Comparing scars after 8 months.

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

    Geoffrey C. Gurtner

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

DANA POINT, CALIF. – Scar formation and fibrosis can be reduced by altering the mechanical environment of wounds, results from a phase I study found.

At the Summit in Aesthetic Medicine, sponsored by Skin Disease Education Foundation (SDEF), Dr. Geoffrey C. Gurtner presented findings from a study in which nine patients undergoing elective abdominal surgery were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

©Neodyne Biosciences, Inc
Comparing scars after 8 months.

The device, manufactured by Neodyne Biosciences, looks like a Band-Aid strip and is stretched over the incision after sutures are removed. It conforms to the wound and adheres to skin, creating "a compressive region that has no level of mechanical stimulation or distractive strain," said Dr. Gurtner, professor of surgery at Stanford (Calif.) University. "Essentially, you create stress risers in the unwounded skin and a mechanically privileged environment in the wounded skin."

A panel of three independent plastic surgeons reviewed 18 photos of the scars (nine treated, nine control) taken 6-12 months after surgery (Ann. Surg. 2011 May 19 [doi: 10.1097/SLA.0b013e318220b159]). They used a visual analog scale (VAS) that ranged from 0 (very good scar) to 100 (very poor hypertrophic scar).

Dr. Gurtner reported that the average VAS score in the treated group was 18.6, while the average VAS score in the control group was 50.5, a difference that was statistically significant (P = .0039). "In none of the cases was the treated scar worse than the control scar, which I think is different than some of the biologic agents we’ve seen over the last few years," he said.*

A panel of lay persons who reviewed the photos reported similar results that favored the treated group (P = .004).

In earlier mouse studies of wound environment manipulation, Dr. Gurtner and his associates found that focal adhesion kinase (FAK) is a critical regulator in the formation of hypertrophic scars. He described FAK as "a molecule that exists on the inner surface of cell membranes and transmits forces that are set in the external extracellular matrix to the inside of the cell. FAK transmits those forces into biological or biochemical cues that then turn on genes in the nucleus and make the cells do different things. This seems to be a very important molecule in the ability of us to produce hypertrophic scars in mice. If you take out FAK, you can prevent hypertrophic scar formation."

    Geoffrey C. Gurtner

FAK is a target that has been examined extensively in cancer, Dr. Gurtner said, suggesting that in the next few years, "We should have products that will not only be able to treat incision wounds but will also be able to treat large burn injuries. You need to fool the cells into thinking they’re in a different mechanical environment, either by using small molecule or pharmacologic blocking therapies such as fat inhibitors, or by using biomaterials that provide cues in a controlled way that minimize the amount of mechanical stimulation that the fibroblasts feel in the healing wound so as to mitigate the inflammation and subsequent fibrosis."

The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne.

SDEF and this news organization are owned by Elsevier.

*Correction 8/22/11: An earlier version of this story misstated the VAS scores for the two groups of patients.

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EXPERT ANALYSIS FROM THE SDEF SUMMIT IN AESTHETIC MEDICINE

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Inside the Article

Vitals

Major Finding: The average VAS score in the treated group was 50.5, while the average VAS score in the control group was 18.6, a statistically significant difference (P = .004).

Data Source: Nine patients undergoing elective abdominal surgery who were treated postoperatively with a stress-shielding polymer on one side while the other side was treated with standard wound care.

Disclosures: The study was supported by a Wallace H. Coulter Translational Partners Grant; the Armed Forces Institute of Regenerative Medicine; the Hagey Family Endowed Fund in Stem Cell Research and Regenerative Medicine; and the Oak Foundation. Neodyne Biosciences supplied the surgical dressings used in the study. Dr. Gurtner disclosed that he holds an equity interest in Neodyne. SDEF and this news organization are owned by Elsevier.

FDA-Approved PMMA Filler Gives Cheeks a Lift

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FDA-Approved PMMA Filler Gives Cheeks a Lift

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

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BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

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FROM THE ANNUAL MEETING OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY

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Inside the Article

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Major Finding: The lipoatrophy-treated patients increased one grade across the board, and the physician-assessed aesthetic score improved 96%

Data Source: Interim results from an open-label, multicenter safety and efficacy trial of Artefill in 24 patients.

Disclosures: The study is sponsored by Suneva Medical. Dr. Mills also disclosed a financial relationship with Allergan.

Know Thy Laser and Other Treatment Pearls

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Know Thy Laser and Other Treatment Pearls

DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

 

 

If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

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DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

 

 

If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

DANA POINT, CALIF. – Be wary of clinicians who claim that they never have complications from laser surgery procedures, Dr. A. Jay Burns advised physicians to tell their patients at the Summit in Aesthetic Medicine.

Such clinicians "are either liars, or they’ve only practiced for about 5 minutes," Dr. Burns, of the Dallas Plastic Surgery Institute, said at the meeting, sponsored by Skin Disease Education Foundation (SDEF). "I tell my patients to run from them. We all have complications."

In general, he continued, complications "decrease the better you are trained and the more detail-oriented you are. I don’t know how you legislate that. You also have to care; you have to have compassion."

During separate presentations, he and Dr. Eric F. Bernstein, a board-certified dermatologist who practices laser surgery in Ardmore, Pa., offered practical tips on how to best prevent complications from laser surgery, including the following:

Know thy laser. "In general, there is less margin for error the cheaper the device, the more corners cut in research and development, the smaller the spot size, and the use of manual treatment versus scanned treatment," Dr. Burns said. "Complications can be minimized by good technique and good postoperative care."

Don’t take treatment advice from sales representatives. "You are responsible for the treatment no matter what, so research the science and talk to colleagues," Dr. Bernstein said. "I have three words for sales reps bringing a device they tout as safe and effective: ‘Have a seat!’ Sales reps who believe in their products will happily be your first patient, and they will come back for follow-up. You can count on it."

Take note of special patient populations. Make sure to ask patients about isotretinoin use. "Most of my colleagues and I wait 6 months after patients have discontinued isotretinoin before laser treatment," Dr. Bernstein said. "In most situations I think that’s the standard of care."

Depending on the laser, he prescribes valacyclovir as prophylaxis in patients with a history of herpes simplex virus or for ablative procedures in any patient. He said that he does not treat patients who have taken gold therapy at any time in their life with lasers, as their skin "will turn gray or black at the site of every laser pulse. This is on my consent form."

Patients with systemic lupus and other connective tissue diseases can flare locally and possibly systemically after treatment with vascular lasers, so he generally avoids treating these patients or treats with caution after spot testing.

He does not treat pregnant patients with elective laser procedures, "although I don’t believe there is any risk from the lasers I use," Dr. Bernstein said. "I treated my wife during her pregnancy because she had so much free time from work during that time. However, we’re in America, and until the legal climate changes dramatically, I just avoid performing elective laser treatments on pregnant patients. Tattoo removal is probably the one case where it is actually less advised to treat patients during pregnancy for medical reasons. That’s because the tattoo pigment as a chemical can become mobilized following laser treatment, not because of the laser."

Sun exposure "is probably the biggest issue that causes complications in patients," he continued. "I tell every laser surgeon to respect melanin pigment, as it is an unwanted target in the skin and can absorb laser light, making the epidermis an unwanted target. In addition, a tan makes for more risk of post-inflammatory hyper- or hypopigmentation following treatment. Patients are rarely honest about their sun exposure."

Wear protective eyewear while operating the laser. Dr. Bernstein locks the door to the laser room while he treats patients "because I think it’s inappropriate to have laser glasses outside your room and open the door and walk in with the glasses, exposing the people outside the door or walking by to laser light. This may be against certain regulations, since those outside the room would have a hard time entering in the event of a problem, but I am never alone in a room with a patient, and prefer this rule for eye safety."

When someone hands you a pair of protective laser glasses, "look at the wavelength ranges and make sure that they correspond to the wavelength of the laser," he advised. "We all check each other’s glasses to make sure they are the right wavelength. Obviously, it’s best to have only one wavelength per room and have glasses for that laser; however, in my office that’s not possible."

 

 

If patients say they’re in pain, stop. Some people have a low tolerance for pain, "but that’s not the time to debate their pain threshold," Dr. Burns noted.

Debridement and pretreatment. In Dr. Burns’ practice, the regimen for all patients undergoing ablative resurfacing includes changes of Flexzan wound dressing and debridement at 1, 3, and 5 days, cephalexin 250 mg t.i.d. for 5 days, and valacyclovir 500 mg b.i.d. for 10 days.

Expect maintenance treatments for laser hair removal cases. "Everybody is different, but because of the hair cycle it takes four to six initial treatments, 6 weeks apart, to expose all of the hair in a given area to the laser," Dr. Bernstein said. "Maintenance treatments are always required to keep all of the hair away in a given area."

Prior to performing hair removal procedures in the perioral region, he places two folded pieces of 4-by-4-inch gauze into the patient’s mouth to protect the teeth. "Use nonstick gauze with braces or be ready for a half-hour extraction," he said.

Dr. Bernstein disclosed that he has received research support from Syneron, Cynosure, and Cutera, and Solta Medical. He also serves as a paid consultant for Tria Beauty.

Dr. Burns disclosed that he receives equipment discounts from Cutera, Cynosure, Palomar, Sciton, and Aesthetic Medical Lasers; research support from Sciton, Solta Medical, Ulthera, and Zeltiq; and consulting fees from Ulthera and Zeltiq. He also holds stock in SkinMedica and Zeltiq.

SDEF and this news organization are owned by Elsevier.

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