Aesthetic Dermatology

Liposonix is considered to be a nonsurgical treatment for body contouring that uses high-intensity focused ultrasound (HIFU) to disrupt adipocytes percutaneously. We wanted to find out about its efficacy, effectiveness, and so forth. The technique delivers energy across the skin surface at a relatively low intensity, but brings this energy to a sharp focus in the subcutaneous fat. At the skin surface, the intensity of the ultrasound energy is low enough so that no damage occurs. The focusing of the ultrasound beam at specific depths beneath the epidermis, combined with proprietary application techniques, results in adipose tissue disruption. Once adipocytes have been disrupted, chemotactic signals activate the body’s inflammatory response mechanisms. Macrophage cells are attracted to the area to engulf and transport the lipids and cell debris. This results in an overall reduction in local adipose tissue volume. Our clinical and histologic studies will show exactly what happens under the skin. We did a series of studies on gross pathology and histology, and we tried to correlate these with the clinical results. The histologies show clearly that adipocytes are disrupted by HIFU. The pathologies show the lesions, but they are always at a safe distance from dermis or the epidermis. The correlation between focal depth, energy levels, and clinical results is evident. The average circumference reduction after treatment of the abdomen and waist is 4-5 cm. Liposonix turns out to be a safe and effective technique for
nonsurgical body sculpting by reduction of fat deposits.

*For a PDF of the full article, click on the link to the left of this introduction.

Liposonix is considered to be a nonsurgical treatment for body contouring that uses high-intensity focused ultrasound (HIFU) to disrupt adipocytes percutaneously. We wanted to find out about its efficacy, effectiveness, and so forth. The technique delivers energy across the skin surface at a relatively low intensity, but brings this energy to a sharp focus in the subcutaneous fat. At the skin surface, the intensity of the ultrasound energy is low enough so that no damage occurs. The focusing of the ultrasound beam at specific depths beneath the epidermis, combined with proprietary application techniques, results in adipose tissue disruption. Once adipocytes have been disrupted, chemotactic signals activate the body’s inflammatory response mechanisms. Macrophage cells are attracted to the area to engulf and transport the lipids and cell debris. This results in an overall reduction in local adipose tissue volume. Our clinical and histologic studies will show exactly what happens under the skin. We did a series of studies on gross pathology and histology, and we tried to correlate these with the clinical results. The histologies show clearly that adipocytes are disrupted by HIFU. The pathologies show the lesions, but they are always at a safe distance from dermis or the epidermis. The correlation between focal depth, energy levels, and clinical results is evident. The average circumference reduction after treatment of the abdomen and waist is 4-5 cm. Liposonix turns out to be a safe and effective technique for
nonsurgical body sculpting by reduction of fat deposits.

*For a PDF of the full article, click on the link to the left of this introduction.

Liposonix is considered to be a nonsurgical treatment for body contouring that uses high-intensity focused ultrasound (HIFU) to disrupt adipocytes percutaneously. We wanted to find out about its efficacy, effectiveness, and so forth. The technique delivers energy across the skin surface at a relatively low intensity, but brings this energy to a sharp focus in the subcutaneous fat. At the skin surface, the intensity of the ultrasound energy is low enough so that no damage occurs. The focusing of the ultrasound beam at specific depths beneath the epidermis, combined with proprietary application techniques, results in adipose tissue disruption. Once adipocytes have been disrupted, chemotactic signals activate the body’s inflammatory response mechanisms. Macrophage cells are attracted to the area to engulf and transport the lipids and cell debris. This results in an overall reduction in local adipose tissue volume. Our clinical and histologic studies will show exactly what happens under the skin. We did a series of studies on gross pathology and histology, and we tried to correlate these with the clinical results. The histologies show clearly that adipocytes are disrupted by HIFU. The pathologies show the lesions, but they are always at a safe distance from dermis or the epidermis. The correlation between focal depth, energy levels, and clinical results is evident. The average circumference reduction after treatment of the abdomen and waist is 4-5 cm. Liposonix turns out to be a safe and effective technique for
nonsurgical body sculpting by reduction of fat deposits.

*For a PDF of the full article, click on the link to the left of this introduction.

Numerous nonsurgical techniques and devices have sought to reproduce the effectiveness of liposuction. Unfortunately, the vast majority of these has fallen short of adequate results or has been plagued with complications. UltraShape (UltraShape; Yoqneam, Israel) is a device that is able to accomplish the reduction of the subcutaneous fat with a procedure that is both comfortable and leads to good patient satisfaction. Its design of a nonthermal ultrasonic energy is able to produce cavitation leading to fat cell lysis while sparing adjacent blood vessels and nerves. Although the results are not equivalent to surgical results, this device will offer a safe and effective alternative for patients who are apprehensive about undergoing liposuction.

*For a PDF of the full article, click on the link to the left of this introduction.

Numerous nonsurgical techniques and devices have sought to reproduce the effectiveness of liposuction. Unfortunately, the vast majority of these has fallen short of adequate results or has been plagued with complications. UltraShape (UltraShape; Yoqneam, Israel) is a device that is able to accomplish the reduction of the subcutaneous fat with a procedure that is both comfortable and leads to good patient satisfaction. Its design of a nonthermal ultrasonic energy is able to produce cavitation leading to fat cell lysis while sparing adjacent blood vessels and nerves. Although the results are not equivalent to surgical results, this device will offer a safe and effective alternative for patients who are apprehensive about undergoing liposuction.

*For a PDF of the full article, click on the link to the left of this introduction.

Numerous nonsurgical techniques and devices have sought to reproduce the effectiveness of liposuction. Unfortunately, the vast majority of these has fallen short of adequate results or has been plagued with complications. UltraShape (UltraShape; Yoqneam, Israel) is a device that is able to accomplish the reduction of the subcutaneous fat with a procedure that is both comfortable and leads to good patient satisfaction. Its design of a nonthermal ultrasonic energy is able to produce cavitation leading to fat cell lysis while sparing adjacent blood vessels and nerves. Although the results are not equivalent to surgical results, this device will offer a safe and effective alternative for patients who are apprehensive about undergoing liposuction.

*For a PDF of the full article, click on the link to the left of this introduction.

PHOENIX — Cosmetic dermatology procedures require patient education and thorough consent, a panel of four physicians agreed during a discussion of how best to manage any complications that do occur.

Among the questions that were discussed: Do you give a patient a refund if a complication occurs? Do you charge an unhappy patient for a touch-up? When does a complication with hyaluronic acid warrant reversal with hyaluronidase? Also, is it necessary to get informed consent each time an established patient comes in for a series of treatments?

Dr. Ken K. Lee posed these and other questions as he moderated this session at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

If a bruise occurs under the eye, for example, do you give a refund or offer free services? asked Dr. Lee, director of dermatologic and laser surgery at Oregon Health and Science University, Portland.

"Bruises do occur. It's in the informed consent; that is the beauty of the multiple consent form," said Dr. Timothy Flynn, who is in private practice in Cary, N.C. Be compassionate and discuss strategies to avoid bruising the next time, he said. "But, no, I would not give a refund—it is within the expected risks."

"I would not give a refund either," said Dr. Joel L. Cohen, a dermatologist in Englewood, Colo. But, "I might see if they can meet with someone in my office about makeup, at no charge."

Dr. Dee Anna Glaser agreed. "I do pulsed dye laser if they are very upset about this, at no charge. But we don't give refunds." Dr. Glaser is a professor of dermatology at St. Louis University.

Dr. Lee asked the panel for advice when a cosmetic patient presents with a bluish tinge or a Tyndall effect from a more diffuse nodule in their tear trough 1 month after hyaluronic acid injection.

Calculate how much hyaluronic acid was injected, and use hyaluronidase to reverse the effect, Dr. Flynn suggested.

"Tell the patient you are going to melt it away. You have to warn them you are going to melt most of the hyaluronic acid in their face" as well, he said.

"I rarely use hyaluronidase," said Dr. Roberta D. Sengelmann, a dermatologic surgeon in private practice in Santa Barbara, Calif., and St. Louis. "If you use the hyaluronidase, you will really erase their correction." Instead, she discusses camouflage and other options with the patient.

Dr. Lee also asked about treating a woman with "rock hard nodules" under her eyes, for example, 1 year after poly-

Dr. Sengelmann said she would do a biopsy. Dr. Glaser said 1 year is unusually long for such a complication to arise—most develop within the first few months post treatment.

Dr. Sengelmann asked the panel if they charge for hyaluronidase if a patient is referred for a Tyndall effect complication. "I don't charge for the hyaluronidase … or charge them anything extra," Dr. Flynn said. "I kind of feel bad for these people."

"If it's my complication, I do not charge them," Dr. Cohen said. "If it's someone else's patient … I do." He estimated that hyaluronidase costs about $50 for a single-use vial. "There is a risk of anaphylaxis. You need to get their consent," he added.

Dr. Lee next asked the panel if they typically charge when outcomes do not meet their own or the patient's expectations.

"If the problem was not enough volume, we charge for whatever we use in terms of filler," Dr. Flynn said. "Toxins are sometimes different. With an unhappy patient, I can treat with more toxin at no charge."

One challenge is when a patient is willing or able to pay for only a small amount of product but wants a full effect. Dr. Cohen suggested handing a mirror to a one-syringe patient. "Ask them at that point if they want an additional syringe now or later," he said. "Sometimes if I look at a patient a few weeks later and I see I could have done better, I give them a little more at no charge."

Dr. Glaser also offered a strategy with botulinum toxin. "Sometimes when I am really trying to get the patient to use a little more toxin and they are reluctant, I tell them I will do the next 5 U for free this time and if they like the result, they will pay next time."

Dr. Sengelmann typically asks her new patients to return 2–3 weeks after an initial treatment to address any concerns. "If I feel I did not achieve a result, I will give them 5 U, sometimes 10. That is a great way to build rapport with patients."

How dermatologists get consent and whether they should get it for every treatment were Dr. Lee's next concerns.

"The nurse provides the consent form. I come back in the room and ask if they have any questions, and I cosign it," Dr. Sengelmann said. "They sign the same consent each time they come in for a treatment."

"I usually don't sign for Botox and fillers, the nurse signs it," Dr. Glaser said. "We have a form with multiple lines, and we get consent for each and every patient."

In Dr. Cohen's practice, a medical assistant asks patients to sign the consent form. "But I review what can happen [such as] bruising, lumps, and bumps." He also asks patients to let him know if they experience excessive pain or "anything purple they don't think is bruising."

Dr. Glaser said that she has "to remind [patients] that even though they have had no complication to date, the risk is the same with each and every injection."

"I re-consent every time," Dr. Flynn said. "I just want to remind everyone there are more and more attorneys graduating each and every year. Remember the trial attorneys are not your friends."

How do you get informed consent? Do you get it every time an established patient comes in for treatment?

Source Dr. Lee

'They sign the same consent each time they come in for a treatment.'

Source Dr. Sengelmann

A medical assistant asks patients to sign the consent form, 'but I review what can happen.'

Source Dr. Cohen

'We have a form with multiple lines, and we get consent for each and every patient.'

Source Dr. Glaser

PHOENIX — Cosmetic dermatology procedures require patient education and thorough consent, a panel of four physicians agreed during a discussion of how best to manage any complications that do occur.

Among the questions that were discussed: Do you give a patient a refund if a complication occurs? Do you charge an unhappy patient for a touch-up? When does a complication with hyaluronic acid warrant reversal with hyaluronidase? Also, is it necessary to get informed consent each time an established patient comes in for a series of treatments?

Dr. Ken K. Lee posed these and other questions as he moderated this session at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

If a bruise occurs under the eye, for example, do you give a refund or offer free services? asked Dr. Lee, director of dermatologic and laser surgery at Oregon Health and Science University, Portland.

"Bruises do occur. It's in the informed consent; that is the beauty of the multiple consent form," said Dr. Timothy Flynn, who is in private practice in Cary, N.C. Be compassionate and discuss strategies to avoid bruising the next time, he said. "But, no, I would not give a refund—it is within the expected risks."

"I would not give a refund either," said Dr. Joel L. Cohen, a dermatologist in Englewood, Colo. But, "I might see if they can meet with someone in my office about makeup, at no charge."

Dr. Dee Anna Glaser agreed. "I do pulsed dye laser if they are very upset about this, at no charge. But we don't give refunds." Dr. Glaser is a professor of dermatology at St. Louis University.

Dr. Lee asked the panel for advice when a cosmetic patient presents with a bluish tinge or a Tyndall effect from a more diffuse nodule in their tear trough 1 month after hyaluronic acid injection.

Calculate how much hyaluronic acid was injected, and use hyaluronidase to reverse the effect, Dr. Flynn suggested.

"Tell the patient you are going to melt it away. You have to warn them you are going to melt most of the hyaluronic acid in their face" as well, he said.

"I rarely use hyaluronidase," said Dr. Roberta D. Sengelmann, a dermatologic surgeon in private practice in Santa Barbara, Calif., and St. Louis. "If you use the hyaluronidase, you will really erase their correction." Instead, she discusses camouflage and other options with the patient.

Dr. Lee also asked about treating a woman with "rock hard nodules" under her eyes, for example, 1 year after poly-

Dr. Sengelmann said she would do a biopsy. Dr. Glaser said 1 year is unusually long for such a complication to arise—most develop within the first few months post treatment.

Dr. Sengelmann asked the panel if they charge for hyaluronidase if a patient is referred for a Tyndall effect complication. "I don't charge for the hyaluronidase … or charge them anything extra," Dr. Flynn said. "I kind of feel bad for these people."

"If it's my complication, I do not charge them," Dr. Cohen said. "If it's someone else's patient … I do." He estimated that hyaluronidase costs about $50 for a single-use vial. "There is a risk of anaphylaxis. You need to get their consent," he added.

Dr. Lee next asked the panel if they typically charge when outcomes do not meet their own or the patient's expectations.

"If the problem was not enough volume, we charge for whatever we use in terms of filler," Dr. Flynn said. "Toxins are sometimes different. With an unhappy patient, I can treat with more toxin at no charge."

One challenge is when a patient is willing or able to pay for only a small amount of product but wants a full effect. Dr. Cohen suggested handing a mirror to a one-syringe patient. "Ask them at that point if they want an additional syringe now or later," he said. "Sometimes if I look at a patient a few weeks later and I see I could have done better, I give them a little more at no charge."

Dr. Glaser also offered a strategy with botulinum toxin. "Sometimes when I am really trying to get the patient to use a little more toxin and they are reluctant, I tell them I will do the next 5 U for free this time and if they like the result, they will pay next time."

Dr. Sengelmann typically asks her new patients to return 2–3 weeks after an initial treatment to address any concerns. "If I feel I did not achieve a result, I will give them 5 U, sometimes 10. That is a great way to build rapport with patients."

How dermatologists get consent and whether they should get it for every treatment were Dr. Lee's next concerns.

"The nurse provides the consent form. I come back in the room and ask if they have any questions, and I cosign it," Dr. Sengelmann said. "They sign the same consent each time they come in for a treatment."

"I usually don't sign for Botox and fillers, the nurse signs it," Dr. Glaser said. "We have a form with multiple lines, and we get consent for each and every patient."

In Dr. Cohen's practice, a medical assistant asks patients to sign the consent form. "But I review what can happen [such as] bruising, lumps, and bumps." He also asks patients to let him know if they experience excessive pain or "anything purple they don't think is bruising."

Dr. Glaser said that she has "to remind [patients] that even though they have had no complication to date, the risk is the same with each and every injection."

"I re-consent every time," Dr. Flynn said. "I just want to remind everyone there are more and more attorneys graduating each and every year. Remember the trial attorneys are not your friends."

How do you get informed consent? Do you get it every time an established patient comes in for treatment?

Source Dr. Lee

'They sign the same consent each time they come in for a treatment.'

Source Dr. Sengelmann

A medical assistant asks patients to sign the consent form, 'but I review what can happen.'

Source Dr. Cohen

'We have a form with multiple lines, and we get consent for each and every patient.'

Source Dr. Glaser

PHOENIX — Cosmetic dermatology procedures require patient education and thorough consent, a panel of four physicians agreed during a discussion of how best to manage any complications that do occur.

Among the questions that were discussed: Do you give a patient a refund if a complication occurs? Do you charge an unhappy patient for a touch-up? When does a complication with hyaluronic acid warrant reversal with hyaluronidase? Also, is it necessary to get informed consent each time an established patient comes in for a series of treatments?

Dr. Ken K. Lee posed these and other questions as he moderated this session at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

If a bruise occurs under the eye, for example, do you give a refund or offer free services? asked Dr. Lee, director of dermatologic and laser surgery at Oregon Health and Science University, Portland.

"Bruises do occur. It's in the informed consent; that is the beauty of the multiple consent form," said Dr. Timothy Flynn, who is in private practice in Cary, N.C. Be compassionate and discuss strategies to avoid bruising the next time, he said. "But, no, I would not give a refund—it is within the expected risks."

"I would not give a refund either," said Dr. Joel L. Cohen, a dermatologist in Englewood, Colo. But, "I might see if they can meet with someone in my office about makeup, at no charge."

Dr. Dee Anna Glaser agreed. "I do pulsed dye laser if they are very upset about this, at no charge. But we don't give refunds." Dr. Glaser is a professor of dermatology at St. Louis University.

Dr. Lee asked the panel for advice when a cosmetic patient presents with a bluish tinge or a Tyndall effect from a more diffuse nodule in their tear trough 1 month after hyaluronic acid injection.

Calculate how much hyaluronic acid was injected, and use hyaluronidase to reverse the effect, Dr. Flynn suggested.

"Tell the patient you are going to melt it away. You have to warn them you are going to melt most of the hyaluronic acid in their face" as well, he said.

"I rarely use hyaluronidase," said Dr. Roberta D. Sengelmann, a dermatologic surgeon in private practice in Santa Barbara, Calif., and St. Louis. "If you use the hyaluronidase, you will really erase their correction." Instead, she discusses camouflage and other options with the patient.

Dr. Lee also asked about treating a woman with "rock hard nodules" under her eyes, for example, 1 year after poly-

Dr. Sengelmann said she would do a biopsy. Dr. Glaser said 1 year is unusually long for such a complication to arise—most develop within the first few months post treatment.

Dr. Sengelmann asked the panel if they charge for hyaluronidase if a patient is referred for a Tyndall effect complication. "I don't charge for the hyaluronidase … or charge them anything extra," Dr. Flynn said. "I kind of feel bad for these people."

"If it's my complication, I do not charge them," Dr. Cohen said. "If it's someone else's patient … I do." He estimated that hyaluronidase costs about $50 for a single-use vial. "There is a risk of anaphylaxis. You need to get their consent," he added.

Dr. Lee next asked the panel if they typically charge when outcomes do not meet their own or the patient's expectations.

"If the problem was not enough volume, we charge for whatever we use in terms of filler," Dr. Flynn said. "Toxins are sometimes different. With an unhappy patient, I can treat with more toxin at no charge."

One challenge is when a patient is willing or able to pay for only a small amount of product but wants a full effect. Dr. Cohen suggested handing a mirror to a one-syringe patient. "Ask them at that point if they want an additional syringe now or later," he said. "Sometimes if I look at a patient a few weeks later and I see I could have done better, I give them a little more at no charge."

Dr. Glaser also offered a strategy with botulinum toxin. "Sometimes when I am really trying to get the patient to use a little more toxin and they are reluctant, I tell them I will do the next 5 U for free this time and if they like the result, they will pay next time."

Dr. Sengelmann typically asks her new patients to return 2–3 weeks after an initial treatment to address any concerns. "If I feel I did not achieve a result, I will give them 5 U, sometimes 10. That is a great way to build rapport with patients."

How dermatologists get consent and whether they should get it for every treatment were Dr. Lee's next concerns.

"The nurse provides the consent form. I come back in the room and ask if they have any questions, and I cosign it," Dr. Sengelmann said. "They sign the same consent each time they come in for a treatment."

"I usually don't sign for Botox and fillers, the nurse signs it," Dr. Glaser said. "We have a form with multiple lines, and we get consent for each and every patient."

In Dr. Cohen's practice, a medical assistant asks patients to sign the consent form. "But I review what can happen [such as] bruising, lumps, and bumps." He also asks patients to let him know if they experience excessive pain or "anything purple they don't think is bruising."

Dr. Glaser said that she has "to remind [patients] that even though they have had no complication to date, the risk is the same with each and every injection."

"I re-consent every time," Dr. Flynn said. "I just want to remind everyone there are more and more attorneys graduating each and every year. Remember the trial attorneys are not your friends."

How do you get informed consent? Do you get it every time an established patient comes in for treatment?

Source Dr. Lee

'They sign the same consent each time they come in for a treatment.'

Source Dr. Sengelmann

A medical assistant asks patients to sign the consent form, 'but I review what can happen.'

Source Dr. Cohen

'We have a form with multiple lines, and we get consent for each and every patient.'

Source Dr. Glaser

PHOENIX — Cosmetic dermatologists need to remain ethical in how they choose and promote a product or procedure, as well as how they market their practice to patients, according to Dr. Susan H. Weinkle.

Disclose all industry financial relationships to avoid bias, or even the perception of bias. “If you would be embarrassed in any way to discuss your relationship with a pharmaceutical company with your patients or colleagues, it may be time to reassess,” Dr. Weinkle said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Ethical patient counseling is also important. “If you use off-label products in your office, you have to make sure the patient understands what it means,” Dr. Weinkle said. Prior to approval of a cosmetic indication for poly-L-lactic acid injection (Sculptura Aesthetic, Sanofi-Aventis) in July 2009. "I had to explain to all patients it was approved for HIV atrophy, and I was choosing to use for an off-label indication."

Dermatologists are under scrutiny from the government and consumer advocates. “We are obliged to maintain a high standard of safety and maintain the public trust,” Dr. Weinkle said. “When I recommend something, I have to know I am recommending it for the right reason. Would I use it to treat myself and my mother?” Choose a particular laser, for example, because it is the best treatment for a particular patient, not because a payment needs to be made on the device.

Participation on industry advisory panels is appropriate for faculty, she said. It also is ethical to accept reasonable reimbursement for travel, lodging, and meal expenses from industry. Progress in medicine is made in part because of alliances between physicians and industry. At the same time, it is imperative to avoid professional bias or even the appearance of such bias. “If we are working for a company or doing a project—we are human beings—we have to acknowledge there could be professional bias,” she said.

Full disclosure of all relevant conflicts of interest includes interactions with the media, such as granting an interview to a magazine or television station. Also, if you do medical writing, beware of too much delegation. “If you write an article for one of our journals, make sure you are involved and review it,” she said. Disclose any role of other people involved.

Remain ethical when marketing or promoting cosmetic dermatology services. “There are more advertisements near my practice for dermatologists than attorneys,” said Dr. Weinkle, a private practice dermatologist in Bradenton, Fla. She said she had no relevant disclosures related to this presentation.

A final tip from Dr. Weinkle: Review the American Medical Association's Code of Medical Ethics, which is available at www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml.

Visit www.youtube.com/SkinAndAllergyNews for a video interview with Dr. Weinkle explaining more about ethics and bias.

PHOENIX — Cosmetic dermatologists need to remain ethical in how they choose and promote a product or procedure, as well as how they market their practice to patients, according to Dr. Susan H. Weinkle.

Disclose all industry financial relationships to avoid bias, or even the perception of bias. “If you would be embarrassed in any way to discuss your relationship with a pharmaceutical company with your patients or colleagues, it may be time to reassess,” Dr. Weinkle said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Ethical patient counseling is also important. “If you use off-label products in your office, you have to make sure the patient understands what it means,” Dr. Weinkle said. Prior to approval of a cosmetic indication for poly-L-lactic acid injection (Sculptura Aesthetic, Sanofi-Aventis) in July 2009. "I had to explain to all patients it was approved for HIV atrophy, and I was choosing to use for an off-label indication."

Dermatologists are under scrutiny from the government and consumer advocates. “We are obliged to maintain a high standard of safety and maintain the public trust,” Dr. Weinkle said. “When I recommend something, I have to know I am recommending it for the right reason. Would I use it to treat myself and my mother?” Choose a particular laser, for example, because it is the best treatment for a particular patient, not because a payment needs to be made on the device.

Participation on industry advisory panels is appropriate for faculty, she said. It also is ethical to accept reasonable reimbursement for travel, lodging, and meal expenses from industry. Progress in medicine is made in part because of alliances between physicians and industry. At the same time, it is imperative to avoid professional bias or even the appearance of such bias. “If we are working for a company or doing a project—we are human beings—we have to acknowledge there could be professional bias,” she said.

Full disclosure of all relevant conflicts of interest includes interactions with the media, such as granting an interview to a magazine or television station. Also, if you do medical writing, beware of too much delegation. “If you write an article for one of our journals, make sure you are involved and review it,” she said. Disclose any role of other people involved.

Remain ethical when marketing or promoting cosmetic dermatology services. “There are more advertisements near my practice for dermatologists than attorneys,” said Dr. Weinkle, a private practice dermatologist in Bradenton, Fla. She said she had no relevant disclosures related to this presentation.

A final tip from Dr. Weinkle: Review the American Medical Association's Code of Medical Ethics, which is available at www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml.

Visit www.youtube.com/SkinAndAllergyNews for a video interview with Dr. Weinkle explaining more about ethics and bias.

PHOENIX — Cosmetic dermatologists need to remain ethical in how they choose and promote a product or procedure, as well as how they market their practice to patients, according to Dr. Susan H. Weinkle.

Disclose all industry financial relationships to avoid bias, or even the perception of bias. “If you would be embarrassed in any way to discuss your relationship with a pharmaceutical company with your patients or colleagues, it may be time to reassess,” Dr. Weinkle said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Ethical patient counseling is also important. “If you use off-label products in your office, you have to make sure the patient understands what it means,” Dr. Weinkle said. Prior to approval of a cosmetic indication for poly-L-lactic acid injection (Sculptura Aesthetic, Sanofi-Aventis) in July 2009. "I had to explain to all patients it was approved for HIV atrophy, and I was choosing to use for an off-label indication."

Dermatologists are under scrutiny from the government and consumer advocates. “We are obliged to maintain a high standard of safety and maintain the public trust,” Dr. Weinkle said. “When I recommend something, I have to know I am recommending it for the right reason. Would I use it to treat myself and my mother?” Choose a particular laser, for example, because it is the best treatment for a particular patient, not because a payment needs to be made on the device.

Participation on industry advisory panels is appropriate for faculty, she said. It also is ethical to accept reasonable reimbursement for travel, lodging, and meal expenses from industry. Progress in medicine is made in part because of alliances between physicians and industry. At the same time, it is imperative to avoid professional bias or even the appearance of such bias. “If we are working for a company or doing a project—we are human beings—we have to acknowledge there could be professional bias,” she said.

Full disclosure of all relevant conflicts of interest includes interactions with the media, such as granting an interview to a magazine or television station. Also, if you do medical writing, beware of too much delegation. “If you write an article for one of our journals, make sure you are involved and review it,” she said. Disclose any role of other people involved.

Remain ethical when marketing or promoting cosmetic dermatology services. “There are more advertisements near my practice for dermatologists than attorneys,” said Dr. Weinkle, a private practice dermatologist in Bradenton, Fla. She said she had no relevant disclosures related to this presentation.

A final tip from Dr. Weinkle: Review the American Medical Association's Code of Medical Ethics, which is available at www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml.

Visit www.youtube.com/SkinAndAllergyNews for a video interview with Dr. Weinkle explaining more about ethics and bias.

PHOENIX — Adding laser lipolysis to radiofrequency tightening procedures for submental and jowl area fat did not significantly increase patient satisfaction, based on the results of a small study.

"So my take-home message [is] maybe less is more," Dr. Susan Van Dyke said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She and her colleagues studied 36 patients. One group of 13 patients received monopolar radiofrequency treatment alone; 10 were treated with laser lipolysis alone; and 13 were treated with a combination at the same sitting.

The investigators compared patient satisfaction and blinded evaluator assessment among the different fat reduction treatments. Patient satisfaction "in private practice is what it is all about," said Dr. Van Dyke, a cosmetic dermatologist in private practice in Paradise Valley, Ariz.

Monopolar radiofrequency provides immediate collagen contracting with better remodeling over time. The treatment can produce a nice improvement in the neckline and jawline—a better contour, Dr. Van Dyke said. "You get nice tightening with radiofrequency alone." Patients were treated to the usual end point of some discomfort, described as, "It hurts, but I can tolerate it for a while."

The patients and blinded assessors rated submental tightening on a 1- to 5-point scale at 6 months. Radiofrequency treatment alone yielded an average 3.6 patient satisfaction rating. Blinded raters, who gauged response using standardized clinical photos, gave this treatment an average rating of 3.4.

Laser lipolysis uses a laser to heat and dissolve fat cells and a 1- to 2-mm cannula to drain the liquefied fat. The patients in the laser lipolysis monotherapy group were treated with a 10-W device with a 1,064-nm Nd:YAG laser. The treatment end point was a surface temperature of 102°–104°F.

Average patient satisfaction with this approach was 3.1. Blinded observers rated response higher, an average of 3.9. "We had six complications," Dr. Van Dyke said. "All resolved, but this may be why patients were not as satisfied."

Patients in the combined treatment group rated their satisfaction an average of 3.6. "Combined treatment seemed to be just as good as radiofrequency by itself; both were rated 3.6 by patients," Dr. Van Dyke said.

The blinded raters gave the combination an average score of 3.7, slightly below their 3.9 rating for results with laser lipolysis alone.

"I care about the satisfaction of my patients," Dr. Van Dyke said. "From a clinical standpoint, patients like the radiofrequency and the combination, and are a little less enthusiastic about laser lipolysis alone."

Dr. Van Dyke is on the speakers bureau for Solta Medical Inc., Lumenis Ltd., Stiefel Laboratories Inc. (RevaléSkin), and Valeant Pharmaceuticals International and is a stockholder in Medicis Pharmaceutical Corp. and Allergan Inc.

PHOENIX — Adding laser lipolysis to radiofrequency tightening procedures for submental and jowl area fat did not significantly increase patient satisfaction, based on the results of a small study.

"So my take-home message [is] maybe less is more," Dr. Susan Van Dyke said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She and her colleagues studied 36 patients. One group of 13 patients received monopolar radiofrequency treatment alone; 10 were treated with laser lipolysis alone; and 13 were treated with a combination at the same sitting.

The investigators compared patient satisfaction and blinded evaluator assessment among the different fat reduction treatments. Patient satisfaction "in private practice is what it is all about," said Dr. Van Dyke, a cosmetic dermatologist in private practice in Paradise Valley, Ariz.

Monopolar radiofrequency provides immediate collagen contracting with better remodeling over time. The treatment can produce a nice improvement in the neckline and jawline—a better contour, Dr. Van Dyke said. "You get nice tightening with radiofrequency alone." Patients were treated to the usual end point of some discomfort, described as, "It hurts, but I can tolerate it for a while."

The patients and blinded assessors rated submental tightening on a 1- to 5-point scale at 6 months. Radiofrequency treatment alone yielded an average 3.6 patient satisfaction rating. Blinded raters, who gauged response using standardized clinical photos, gave this treatment an average rating of 3.4.

Laser lipolysis uses a laser to heat and dissolve fat cells and a 1- to 2-mm cannula to drain the liquefied fat. The patients in the laser lipolysis monotherapy group were treated with a 10-W device with a 1,064-nm Nd:YAG laser. The treatment end point was a surface temperature of 102°–104°F.

Average patient satisfaction with this approach was 3.1. Blinded observers rated response higher, an average of 3.9. "We had six complications," Dr. Van Dyke said. "All resolved, but this may be why patients were not as satisfied."

Patients in the combined treatment group rated their satisfaction an average of 3.6. "Combined treatment seemed to be just as good as radiofrequency by itself; both were rated 3.6 by patients," Dr. Van Dyke said.

The blinded raters gave the combination an average score of 3.7, slightly below their 3.9 rating for results with laser lipolysis alone.

"I care about the satisfaction of my patients," Dr. Van Dyke said. "From a clinical standpoint, patients like the radiofrequency and the combination, and are a little less enthusiastic about laser lipolysis alone."

Dr. Van Dyke is on the speakers bureau for Solta Medical Inc., Lumenis Ltd., Stiefel Laboratories Inc. (RevaléSkin), and Valeant Pharmaceuticals International and is a stockholder in Medicis Pharmaceutical Corp. and Allergan Inc.

PHOENIX — Adding laser lipolysis to radiofrequency tightening procedures for submental and jowl area fat did not significantly increase patient satisfaction, based on the results of a small study.

"So my take-home message [is] maybe less is more," Dr. Susan Van Dyke said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She and her colleagues studied 36 patients. One group of 13 patients received monopolar radiofrequency treatment alone; 10 were treated with laser lipolysis alone; and 13 were treated with a combination at the same sitting.

The investigators compared patient satisfaction and blinded evaluator assessment among the different fat reduction treatments. Patient satisfaction "in private practice is what it is all about," said Dr. Van Dyke, a cosmetic dermatologist in private practice in Paradise Valley, Ariz.

Monopolar radiofrequency provides immediate collagen contracting with better remodeling over time. The treatment can produce a nice improvement in the neckline and jawline—a better contour, Dr. Van Dyke said. "You get nice tightening with radiofrequency alone." Patients were treated to the usual end point of some discomfort, described as, "It hurts, but I can tolerate it for a while."

The patients and blinded assessors rated submental tightening on a 1- to 5-point scale at 6 months. Radiofrequency treatment alone yielded an average 3.6 patient satisfaction rating. Blinded raters, who gauged response using standardized clinical photos, gave this treatment an average rating of 3.4.

Laser lipolysis uses a laser to heat and dissolve fat cells and a 1- to 2-mm cannula to drain the liquefied fat. The patients in the laser lipolysis monotherapy group were treated with a 10-W device with a 1,064-nm Nd:YAG laser. The treatment end point was a surface temperature of 102°–104°F.

Average patient satisfaction with this approach was 3.1. Blinded observers rated response higher, an average of 3.9. "We had six complications," Dr. Van Dyke said. "All resolved, but this may be why patients were not as satisfied."

Patients in the combined treatment group rated their satisfaction an average of 3.6. "Combined treatment seemed to be just as good as radiofrequency by itself; both were rated 3.6 by patients," Dr. Van Dyke said.

The blinded raters gave the combination an average score of 3.7, slightly below their 3.9 rating for results with laser lipolysis alone.

"I care about the satisfaction of my patients," Dr. Van Dyke said. "From a clinical standpoint, patients like the radiofrequency and the combination, and are a little less enthusiastic about laser lipolysis alone."

Dr. Van Dyke is on the speakers bureau for Solta Medical Inc., Lumenis Ltd., Stiefel Laboratories Inc. (RevaléSkin), and Valeant Pharmaceuticals International and is a stockholder in Medicis Pharmaceutical Corp. and Allergan Inc.

PHOENIX — Fractional CO₂ lasers provide greater accuracy, control, and predictability for skin resurfacing than do chemical peels, according to Dr. Kimberly Butterwick. However, Dr. Gary Monheit countered that peels are more efficient, safe, and reliable than lasers.

"We know in today's economy [dermatologists are asking] is a laser really worth it?" Dr. Butterwick said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She estimated that an ablative fractional CO₂ laser costs about $1,500 per patient in the first year, but said the device pays off in the long run. "You can make more money treating more patients. You end up working less hard [compared with chemical peels] and making good money," she said.

Patients are willing to pay more for the results provided by laser resurfacing, according to Dr. Butterwick, who is in private practice in San Diego. "Patients will pay $1,000 more if you say they will have a better experience, and you will get rid of more lines."

"The big thing about lasers versus chemical peels is how deep you can go and still be safe," Dr. Butterwick said. A patient concerned with rhytids along his or her upper lip, for example, can be treated safely with a laser.

"If the lines are not too deep, one treatment tends to get rid of the lion's share of the lines above the mouth," she said. Peels can be used, but there is a risk of adverse outcomes. "Scarring and a decreased oral aperture can result with a deeper peel around the mouth," she said.

Laser resurfacing is also less painful, Dr. Butterwick said. "Patients do not require meds, so they can drive there and back, and they don't have to rely on a friend or tell their husband."

A quicker, easier recovery is another benefit of fractional CO₂ lasers. "No longer is there the 2-week redness and healing we saw with older CO₂ lasers. Patients can be functional while they are recovering and can get back to work sooner," she said. "Everyone is healed and in makeup within 6 days in our practice."

The opportunities for instruction are another distinction between the fractional CO₂ laser and chemical peel resurfacing. "You can get education and training in lasers, and you can hardly get any training in peels any more," Dr. Butterwick said.

However, in a subsequent presentation at the meeting, Dr. Monheit argued that chemical peels have a longer track record. "Peels remain the most popular, reliable, and efficacious method of skin resurfacing after more than 75 plus years," said Dr. Monheit, who is in private practice in Birmingham, Ala.

"Chemical peels yield predictable results with safety and efficacy," he said. "You can really [predict] what the patient will have in a reliable period of time."

There is no laser "that can produce results as efficiently and safely as chemical peeling," Dr. Monheit said. "I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would."

Also, chemical peels "can be tailored to patients' needs and downtime, for example, a lunchtime superficial peel," he said.

Dr. Butterwick and Dr. Monheit reported no relevant disclosures.

'I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would.'

Source Dr. Monheit

With the laser, 'you end up working less hard [compared with chemical peels] and making good money.'

Source Dr. Butterwick

PHOENIX — Fractional CO₂ lasers provide greater accuracy, control, and predictability for skin resurfacing than do chemical peels, according to Dr. Kimberly Butterwick. However, Dr. Gary Monheit countered that peels are more efficient, safe, and reliable than lasers.

"We know in today's economy [dermatologists are asking] is a laser really worth it?" Dr. Butterwick said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She estimated that an ablative fractional CO₂ laser costs about $1,500 per patient in the first year, but said the device pays off in the long run. "You can make more money treating more patients. You end up working less hard [compared with chemical peels] and making good money," she said.

Patients are willing to pay more for the results provided by laser resurfacing, according to Dr. Butterwick, who is in private practice in San Diego. "Patients will pay $1,000 more if you say they will have a better experience, and you will get rid of more lines."

"The big thing about lasers versus chemical peels is how deep you can go and still be safe," Dr. Butterwick said. A patient concerned with rhytids along his or her upper lip, for example, can be treated safely with a laser.

"If the lines are not too deep, one treatment tends to get rid of the lion's share of the lines above the mouth," she said. Peels can be used, but there is a risk of adverse outcomes. "Scarring and a decreased oral aperture can result with a deeper peel around the mouth," she said.

Laser resurfacing is also less painful, Dr. Butterwick said. "Patients do not require meds, so they can drive there and back, and they don't have to rely on a friend or tell their husband."

A quicker, easier recovery is another benefit of fractional CO₂ lasers. "No longer is there the 2-week redness and healing we saw with older CO₂ lasers. Patients can be functional while they are recovering and can get back to work sooner," she said. "Everyone is healed and in makeup within 6 days in our practice."

The opportunities for instruction are another distinction between the fractional CO₂ laser and chemical peel resurfacing. "You can get education and training in lasers, and you can hardly get any training in peels any more," Dr. Butterwick said.

However, in a subsequent presentation at the meeting, Dr. Monheit argued that chemical peels have a longer track record. "Peels remain the most popular, reliable, and efficacious method of skin resurfacing after more than 75 plus years," said Dr. Monheit, who is in private practice in Birmingham, Ala.

"Chemical peels yield predictable results with safety and efficacy," he said. "You can really [predict] what the patient will have in a reliable period of time."

There is no laser "that can produce results as efficiently and safely as chemical peeling," Dr. Monheit said. "I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would."

Also, chemical peels "can be tailored to patients' needs and downtime, for example, a lunchtime superficial peel," he said.

Dr. Butterwick and Dr. Monheit reported no relevant disclosures.

'I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would.'

Source Dr. Monheit

With the laser, 'you end up working less hard [compared with chemical peels] and making good money.'

Source Dr. Butterwick

PHOENIX — Fractional CO₂ lasers provide greater accuracy, control, and predictability for skin resurfacing than do chemical peels, according to Dr. Kimberly Butterwick. However, Dr. Gary Monheit countered that peels are more efficient, safe, and reliable than lasers.

"We know in today's economy [dermatologists are asking] is a laser really worth it?" Dr. Butterwick said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

She estimated that an ablative fractional CO₂ laser costs about $1,500 per patient in the first year, but said the device pays off in the long run. "You can make more money treating more patients. You end up working less hard [compared with chemical peels] and making good money," she said.

Patients are willing to pay more for the results provided by laser resurfacing, according to Dr. Butterwick, who is in private practice in San Diego. "Patients will pay $1,000 more if you say they will have a better experience, and you will get rid of more lines."

"The big thing about lasers versus chemical peels is how deep you can go and still be safe," Dr. Butterwick said. A patient concerned with rhytids along his or her upper lip, for example, can be treated safely with a laser.

"If the lines are not too deep, one treatment tends to get rid of the lion's share of the lines above the mouth," she said. Peels can be used, but there is a risk of adverse outcomes. "Scarring and a decreased oral aperture can result with a deeper peel around the mouth," she said.

Laser resurfacing is also less painful, Dr. Butterwick said. "Patients do not require meds, so they can drive there and back, and they don't have to rely on a friend or tell their husband."

A quicker, easier recovery is another benefit of fractional CO₂ lasers. "No longer is there the 2-week redness and healing we saw with older CO₂ lasers. Patients can be functional while they are recovering and can get back to work sooner," she said. "Everyone is healed and in makeup within 6 days in our practice."

The opportunities for instruction are another distinction between the fractional CO₂ laser and chemical peel resurfacing. "You can get education and training in lasers, and you can hardly get any training in peels any more," Dr. Butterwick said.

However, in a subsequent presentation at the meeting, Dr. Monheit argued that chemical peels have a longer track record. "Peels remain the most popular, reliable, and efficacious method of skin resurfacing after more than 75 plus years," said Dr. Monheit, who is in private practice in Birmingham, Ala.

"Chemical peels yield predictable results with safety and efficacy," he said. "You can really [predict] what the patient will have in a reliable period of time."

There is no laser "that can produce results as efficiently and safely as chemical peeling," Dr. Monheit said. "I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would."

Also, chemical peels "can be tailored to patients' needs and downtime, for example, a lunchtime superficial peel," he said.

Dr. Butterwick and Dr. Monheit reported no relevant disclosures.

'I'm seeing a resurgence back to chemical peels because the laser hype has not delivered all it said it would.'

Source Dr. Monheit

With the laser, 'you end up working less hard [compared with chemical peels] and making good money.'

Source Dr. Butterwick

As pressure grows on cosmetics companies to use more environmentally friendly ingredients and packaging, there has been a profound increase in organic/natural and eco claims on “green” beauty products. Terms such as botanical, natural, green, organic, and active naturals are used. Among these terms, only the term “organic” has legal requirements for its use.

There are different standards in the United States and in other countries about what “organic” means. This column will discuss the meaning of the term “organic” and the various organic certifications.

Origin of the Term

The term “organic” as currently used was coined in 1940 by J.I. Rodale, who founded the Rodale publishing empire with the magazine “Organic Farming and Gardening.” In 1992 the U.S. Department of Agriculture (USDA) approved the Organic Label and its accompanying standards; however, this “organic seal” applied mainly to agricultural foods and practices.

Organic Regulation

There was no recognized “organic” label for personal skin care products until 2002. In May of that year, the USDA made it clear, in a policy statement about the National Organic Program (NOP), that producers of nonfood products containing agricultural ingredients were eligible to seek certification. This policy allowed producers of nonfood items to display the iconic round, green “USDA Organic” seal to attest to “authentic” organic claims on certifiers' labels.

In April 2004, however, the USDA issued a surprising Guidance Statement reversing this position, indicating that producers of personal care products would not be eligible to seek certification and had to cease use of the green symbol. There was wavering on this decision until August 2005, when the Organic Consumers Association, representing more than 500,000 members, won a major victory in a lawsuit against the USDA. The outcome of the lawsuit was that nonfood products could now be certified with the organic seal.

This seal offers two kinds of organic certification. If a product contains 95% organic ingredients, it can be labeled as organic. If it contains between 75% and 94% organic ingredients, it can be labeled as “made with XX% organic ingredients.” The nonorganic ingredients must also be screened to ensure they conform to the organic food standards.

Regulatory Bodies

The USDA seal is the most common, but as it really applies to food products, many new standards have been created; however, no one standard has been universally agreed upon. There are various standards that differ from country to country. In addition, some of these standards were created by for-profit businesses that will certify products for a fee. Obviously, there is an inherent bias in this arrangement.

In Europe, one such organization that offers certification is the European Cosmetics Standards Working Group, which has developed the Cosmetics Organic Standard (COSMOS). For more information, visit www.cosmos-standard.org. Another popular certifying organization is NaTrue from Germany (www.natrue.org). This association signed an equivalency agreement with another certifying body in the United States known as the Natural Products Association. Now that these organizations have teamed up, they are a leading certification organization in China.

NaTrue and COSMOS appear to be the most popular certifying bodies in the United States but certification is a competitive field, and every certifying organization wants to claim to have the recognized standard. Other certifying bodies in the United States include NSF International, which was one of the first, and OASIS, which was created by a coalition of beauty product manufacturers.

Each certifying body has its own standards of what constitutes “organic,” and there are discrepancies among them. For example, some standards exclude products originating from livestock that have had any genetic engineering, whereas other standards do not.

Organic Topical Products

Although there are no long-term studies documenting the effects of using topical organic products or ingredients, consumers of organic products are typically as interested in what products do not contain as in what they do contain. The intent of the organic label is to assure consumers that the key cleansing and conditioning ingredients are derived from organically grown plants rather than conventionally grown plants, synthetic chemicals, or petroleum byproducts. In addition, topical organic products exclude or minimize any ingredients that could be considered potentially harmful to people, animals, waterways, or the environment. The rules about which ingredients can and cannot be included vary by regulatory body.

The Precautionary Principle

Sometimes certain ingredients are excluded from products on the basis of research. In other cases, exclusions are based on the “precautionary principle,” which holds that until the cumulative effects of exposures to a broad range of ingredients can be fully assessed, it is best to err on the side of caution and limit use. For example, although many chemical ingredients used in cosmetics are widely considered to be safe, some safety factors have not been fully studied.

It is virtually impossible to assess the cumulative effects of repeated exposures to ingredients found in personal care products that may come from multiple sources. This is important because consumers, especially women, use several skin, hair, and beauty products per day. Typical use of a variety of products could lead to a higher combined rate of exposure than is usually assessed in safety studies. In addition, because of the use of a variety of products, the ingredients could interact, the possibility of which may not be accounted for in single-ingredient safety studies. Furthermore, to accurately establish the baseline of the chemical exposures that people can safely tolerate, it would be necessary to account for all chemical exposures from food, urban smog, industrial waste, and other sources.

Ingredient Cautions

Parabens can be absorbed via the skin and travel into the bloodstream and tissues (NewScientist.com News Service, Jan. 12, 2004). One controversial study even found high concentrations of parabens in breast cancer tissue. Products containing parabens should be avoided by most people who know they are allergic to parabens. There are no convincing data that parabens are harmful in those not allergic to this group of compounds, but many are choosing to avoid products containing this preservative ingredient.

Toluene, which is found in many brands of nail polish, has been associated with detrimental effects on males in utero. Consequently, major companies such as L'Oréal and Revlon, as well as manufacturers of natural and organic products, have taken steps to eliminate toluene from their nail polishes. Toluene can also cause a skin rash, typically on the eyelids, in people who use toluene-containing nail polishes.

Several other ingredients also warrant cautionary notes, but even organic products can cause problems. For example, coconut oil, a popular organic ingredient, can cause acne. Allergies can develop in response to many essential oils and botanicals. In addition, because companies were not able to label their products as organic until recently, there have not been enough clinical research trials on the organic products on the market.

'Natural' Ingredients

It is important to note that products touted as “natural” are not necessarily organic. For example, “active naturals” is a term used by Aveeno to describe ingredients that are found in nature but have been improved upon in the laboratory. An example is the medicinal herb feverfew, which in the Aveeno Ultra-Calming products has had parthenolide removed. Parthenolide can lead to skin inflammation, so products containing feverfew function better as anti-inflammatories without it. Products also may contain natural ingredients such as aloe, chamomile, cucumber, or vitamin E, but if these have not been grown in the required manner, the organic seal cannot be used. In addition, “natural products” may also contain chemicals intended to act as preservatives or to improve texture.

That said, problems can, of course, be associated with ingredients that are natural or organic. For instance, many natural and organic brands contain certain fragrances and essential oils that can cause dermatitis. Organic products containing strong essential oils such as peppermint or rosemary can also irritate or inflame sensitive skin. Chamomile can induce allergies in some people (who may also tend to be allergic to wheat). Furthermore, conventional as well as some natural products contain a “perfume mix” to mask their odor. Components of the perfume mix are rarely listed on the product label because each company uses its own proprietary blend. Even a product listed as 95% organic could contain a perfume mix that might induce allergic reactions in some people.

The Future of Organics

Few product lines can meet the standards of the regulatory organizations, and it is expensive to meet and maintain these standards. There are a few well-made organic lines, such as Juice Beauty and Sophyto. However, organic does not equal efficacy. None of these products can come close to the results of a prescription retinoid.

At this point, organic products have not been subjected to the strict scrutiny of science to evaluate efficacy.

Toluene, found in many brands of nail polish, has been linked to detrimental effects of males in utero.

Source ©Ivan Mateev/iStockphoto.com

As pressure grows on cosmetics companies to use more environmentally friendly ingredients and packaging, there has been a profound increase in organic/natural and eco claims on “green” beauty products. Terms such as botanical, natural, green, organic, and active naturals are used. Among these terms, only the term “organic” has legal requirements for its use.

There are different standards in the United States and in other countries about what “organic” means. This column will discuss the meaning of the term “organic” and the various organic certifications.

Origin of the Term

The term “organic” as currently used was coined in 1940 by J.I. Rodale, who founded the Rodale publishing empire with the magazine “Organic Farming and Gardening.” In 1992 the U.S. Department of Agriculture (USDA) approved the Organic Label and its accompanying standards; however, this “organic seal” applied mainly to agricultural foods and practices.

Organic Regulation

There was no recognized “organic” label for personal skin care products until 2002. In May of that year, the USDA made it clear, in a policy statement about the National Organic Program (NOP), that producers of nonfood products containing agricultural ingredients were eligible to seek certification. This policy allowed producers of nonfood items to display the iconic round, green “USDA Organic” seal to attest to “authentic” organic claims on certifiers' labels.

In April 2004, however, the USDA issued a surprising Guidance Statement reversing this position, indicating that producers of personal care products would not be eligible to seek certification and had to cease use of the green symbol. There was wavering on this decision until August 2005, when the Organic Consumers Association, representing more than 500,000 members, won a major victory in a lawsuit against the USDA. The outcome of the lawsuit was that nonfood products could now be certified with the organic seal.

This seal offers two kinds of organic certification. If a product contains 95% organic ingredients, it can be labeled as organic. If it contains between 75% and 94% organic ingredients, it can be labeled as “made with XX% organic ingredients.” The nonorganic ingredients must also be screened to ensure they conform to the organic food standards.

Regulatory Bodies

The USDA seal is the most common, but as it really applies to food products, many new standards have been created; however, no one standard has been universally agreed upon. There are various standards that differ from country to country. In addition, some of these standards were created by for-profit businesses that will certify products for a fee. Obviously, there is an inherent bias in this arrangement.

In Europe, one such organization that offers certification is the European Cosmetics Standards Working Group, which has developed the Cosmetics Organic Standard (COSMOS). For more information, visit www.cosmos-standard.org. Another popular certifying organization is NaTrue from Germany (www.natrue.org). This association signed an equivalency agreement with another certifying body in the United States known as the Natural Products Association. Now that these organizations have teamed up, they are a leading certification organization in China.

NaTrue and COSMOS appear to be the most popular certifying bodies in the United States but certification is a competitive field, and every certifying organization wants to claim to have the recognized standard. Other certifying bodies in the United States include NSF International, which was one of the first, and OASIS, which was created by a coalition of beauty product manufacturers.

Each certifying body has its own standards of what constitutes “organic,” and there are discrepancies among them. For example, some standards exclude products originating from livestock that have had any genetic engineering, whereas other standards do not.

Organic Topical Products

Although there are no long-term studies documenting the effects of using topical organic products or ingredients, consumers of organic products are typically as interested in what products do not contain as in what they do contain. The intent of the organic label is to assure consumers that the key cleansing and conditioning ingredients are derived from organically grown plants rather than conventionally grown plants, synthetic chemicals, or petroleum byproducts. In addition, topical organic products exclude or minimize any ingredients that could be considered potentially harmful to people, animals, waterways, or the environment. The rules about which ingredients can and cannot be included vary by regulatory body.

The Precautionary Principle

Sometimes certain ingredients are excluded from products on the basis of research. In other cases, exclusions are based on the “precautionary principle,” which holds that until the cumulative effects of exposures to a broad range of ingredients can be fully assessed, it is best to err on the side of caution and limit use. For example, although many chemical ingredients used in cosmetics are widely considered to be safe, some safety factors have not been fully studied.

It is virtually impossible to assess the cumulative effects of repeated exposures to ingredients found in personal care products that may come from multiple sources. This is important because consumers, especially women, use several skin, hair, and beauty products per day. Typical use of a variety of products could lead to a higher combined rate of exposure than is usually assessed in safety studies. In addition, because of the use of a variety of products, the ingredients could interact, the possibility of which may not be accounted for in single-ingredient safety studies. Furthermore, to accurately establish the baseline of the chemical exposures that people can safely tolerate, it would be necessary to account for all chemical exposures from food, urban smog, industrial waste, and other sources.

Ingredient Cautions

Parabens can be absorbed via the skin and travel into the bloodstream and tissues (NewScientist.com News Service, Jan. 12, 2004). One controversial study even found high concentrations of parabens in breast cancer tissue. Products containing parabens should be avoided by most people who know they are allergic to parabens. There are no convincing data that parabens are harmful in those not allergic to this group of compounds, but many are choosing to avoid products containing this preservative ingredient.

Toluene, which is found in many brands of nail polish, has been associated with detrimental effects on males in utero. Consequently, major companies such as L'Oréal and Revlon, as well as manufacturers of natural and organic products, have taken steps to eliminate toluene from their nail polishes. Toluene can also cause a skin rash, typically on the eyelids, in people who use toluene-containing nail polishes.

Several other ingredients also warrant cautionary notes, but even organic products can cause problems. For example, coconut oil, a popular organic ingredient, can cause acne. Allergies can develop in response to many essential oils and botanicals. In addition, because companies were not able to label their products as organic until recently, there have not been enough clinical research trials on the organic products on the market.

'Natural' Ingredients

It is important to note that products touted as “natural” are not necessarily organic. For example, “active naturals” is a term used by Aveeno to describe ingredients that are found in nature but have been improved upon in the laboratory. An example is the medicinal herb feverfew, which in the Aveeno Ultra-Calming products has had parthenolide removed. Parthenolide can lead to skin inflammation, so products containing feverfew function better as anti-inflammatories without it. Products also may contain natural ingredients such as aloe, chamomile, cucumber, or vitamin E, but if these have not been grown in the required manner, the organic seal cannot be used. In addition, “natural products” may also contain chemicals intended to act as preservatives or to improve texture.

That said, problems can, of course, be associated with ingredients that are natural or organic. For instance, many natural and organic brands contain certain fragrances and essential oils that can cause dermatitis. Organic products containing strong essential oils such as peppermint or rosemary can also irritate or inflame sensitive skin. Chamomile can induce allergies in some people (who may also tend to be allergic to wheat). Furthermore, conventional as well as some natural products contain a “perfume mix” to mask their odor. Components of the perfume mix are rarely listed on the product label because each company uses its own proprietary blend. Even a product listed as 95% organic could contain a perfume mix that might induce allergic reactions in some people.

The Future of Organics

Few product lines can meet the standards of the regulatory organizations, and it is expensive to meet and maintain these standards. There are a few well-made organic lines, such as Juice Beauty and Sophyto. However, organic does not equal efficacy. None of these products can come close to the results of a prescription retinoid.

At this point, organic products have not been subjected to the strict scrutiny of science to evaluate efficacy.

Toluene, found in many brands of nail polish, has been linked to detrimental effects of males in utero.

Source ©Ivan Mateev/iStockphoto.com

As pressure grows on cosmetics companies to use more environmentally friendly ingredients and packaging, there has been a profound increase in organic/natural and eco claims on “green” beauty products. Terms such as botanical, natural, green, organic, and active naturals are used. Among these terms, only the term “organic” has legal requirements for its use.

There are different standards in the United States and in other countries about what “organic” means. This column will discuss the meaning of the term “organic” and the various organic certifications.

Origin of the Term

The term “organic” as currently used was coined in 1940 by J.I. Rodale, who founded the Rodale publishing empire with the magazine “Organic Farming and Gardening.” In 1992 the U.S. Department of Agriculture (USDA) approved the Organic Label and its accompanying standards; however, this “organic seal” applied mainly to agricultural foods and practices.

Organic Regulation

There was no recognized “organic” label for personal skin care products until 2002. In May of that year, the USDA made it clear, in a policy statement about the National Organic Program (NOP), that producers of nonfood products containing agricultural ingredients were eligible to seek certification. This policy allowed producers of nonfood items to display the iconic round, green “USDA Organic” seal to attest to “authentic” organic claims on certifiers' labels.

In April 2004, however, the USDA issued a surprising Guidance Statement reversing this position, indicating that producers of personal care products would not be eligible to seek certification and had to cease use of the green symbol. There was wavering on this decision until August 2005, when the Organic Consumers Association, representing more than 500,000 members, won a major victory in a lawsuit against the USDA. The outcome of the lawsuit was that nonfood products could now be certified with the organic seal.

This seal offers two kinds of organic certification. If a product contains 95% organic ingredients, it can be labeled as organic. If it contains between 75% and 94% organic ingredients, it can be labeled as “made with XX% organic ingredients.” The nonorganic ingredients must also be screened to ensure they conform to the organic food standards.

Regulatory Bodies

The USDA seal is the most common, but as it really applies to food products, many new standards have been created; however, no one standard has been universally agreed upon. There are various standards that differ from country to country. In addition, some of these standards were created by for-profit businesses that will certify products for a fee. Obviously, there is an inherent bias in this arrangement.

In Europe, one such organization that offers certification is the European Cosmetics Standards Working Group, which has developed the Cosmetics Organic Standard (COSMOS). For more information, visit www.cosmos-standard.org. Another popular certifying organization is NaTrue from Germany (www.natrue.org). This association signed an equivalency agreement with another certifying body in the United States known as the Natural Products Association. Now that these organizations have teamed up, they are a leading certification organization in China.

NaTrue and COSMOS appear to be the most popular certifying bodies in the United States but certification is a competitive field, and every certifying organization wants to claim to have the recognized standard. Other certifying bodies in the United States include NSF International, which was one of the first, and OASIS, which was created by a coalition of beauty product manufacturers.

Each certifying body has its own standards of what constitutes “organic,” and there are discrepancies among them. For example, some standards exclude products originating from livestock that have had any genetic engineering, whereas other standards do not.

Organic Topical Products

Although there are no long-term studies documenting the effects of using topical organic products or ingredients, consumers of organic products are typically as interested in what products do not contain as in what they do contain. The intent of the organic label is to assure consumers that the key cleansing and conditioning ingredients are derived from organically grown plants rather than conventionally grown plants, synthetic chemicals, or petroleum byproducts. In addition, topical organic products exclude or minimize any ingredients that could be considered potentially harmful to people, animals, waterways, or the environment. The rules about which ingredients can and cannot be included vary by regulatory body.

The Precautionary Principle

Sometimes certain ingredients are excluded from products on the basis of research. In other cases, exclusions are based on the “precautionary principle,” which holds that until the cumulative effects of exposures to a broad range of ingredients can be fully assessed, it is best to err on the side of caution and limit use. For example, although many chemical ingredients used in cosmetics are widely considered to be safe, some safety factors have not been fully studied.

It is virtually impossible to assess the cumulative effects of repeated exposures to ingredients found in personal care products that may come from multiple sources. This is important because consumers, especially women, use several skin, hair, and beauty products per day. Typical use of a variety of products could lead to a higher combined rate of exposure than is usually assessed in safety studies. In addition, because of the use of a variety of products, the ingredients could interact, the possibility of which may not be accounted for in single-ingredient safety studies. Furthermore, to accurately establish the baseline of the chemical exposures that people can safely tolerate, it would be necessary to account for all chemical exposures from food, urban smog, industrial waste, and other sources.

Ingredient Cautions

Parabens can be absorbed via the skin and travel into the bloodstream and tissues (NewScientist.com News Service, Jan. 12, 2004). One controversial study even found high concentrations of parabens in breast cancer tissue. Products containing parabens should be avoided by most people who know they are allergic to parabens. There are no convincing data that parabens are harmful in those not allergic to this group of compounds, but many are choosing to avoid products containing this preservative ingredient.

Toluene, which is found in many brands of nail polish, has been associated with detrimental effects on males in utero. Consequently, major companies such as L'Oréal and Revlon, as well as manufacturers of natural and organic products, have taken steps to eliminate toluene from their nail polishes. Toluene can also cause a skin rash, typically on the eyelids, in people who use toluene-containing nail polishes.

Several other ingredients also warrant cautionary notes, but even organic products can cause problems. For example, coconut oil, a popular organic ingredient, can cause acne. Allergies can develop in response to many essential oils and botanicals. In addition, because companies were not able to label their products as organic until recently, there have not been enough clinical research trials on the organic products on the market.

'Natural' Ingredients

It is important to note that products touted as “natural” are not necessarily organic. For example, “active naturals” is a term used by Aveeno to describe ingredients that are found in nature but have been improved upon in the laboratory. An example is the medicinal herb feverfew, which in the Aveeno Ultra-Calming products has had parthenolide removed. Parthenolide can lead to skin inflammation, so products containing feverfew function better as anti-inflammatories without it. Products also may contain natural ingredients such as aloe, chamomile, cucumber, or vitamin E, but if these have not been grown in the required manner, the organic seal cannot be used. In addition, “natural products” may also contain chemicals intended to act as preservatives or to improve texture.

That said, problems can, of course, be associated with ingredients that are natural or organic. For instance, many natural and organic brands contain certain fragrances and essential oils that can cause dermatitis. Organic products containing strong essential oils such as peppermint or rosemary can also irritate or inflame sensitive skin. Chamomile can induce allergies in some people (who may also tend to be allergic to wheat). Furthermore, conventional as well as some natural products contain a “perfume mix” to mask their odor. Components of the perfume mix are rarely listed on the product label because each company uses its own proprietary blend. Even a product listed as 95% organic could contain a perfume mix that might induce allergic reactions in some people.

The Future of Organics

Few product lines can meet the standards of the regulatory organizations, and it is expensive to meet and maintain these standards. There are a few well-made organic lines, such as Juice Beauty and Sophyto. However, organic does not equal efficacy. None of these products can come close to the results of a prescription retinoid.

At this point, organic products have not been subjected to the strict scrutiny of science to evaluate efficacy.

Toluene, found in many brands of nail polish, has been linked to detrimental effects of males in utero.

Source ©Ivan Mateev/iStockphoto.com