Aesthetic Dermatology

LAS VEGAS — Dermatologists should tell their patients to be skeptical of "peptide" cosmeceuticals and to stick with proven agents, Dr. Kathy A. Fields said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Agents such as palmitoyl pentapeptide-3 have been shown to stimulate collagen production in a skin culture, but as with so many cosmeceutical products, none of the peptides has been proven to be effective in a published clinical trial or has any compelling scientific data, said Dr. Fields, a dermatologist in San Francisco who is a coinventor of Proactiv Solution, the popular acne treatment, and has her own line of cosmeceuticals, Rodan + Fields.

The peptides in cosmeceuticals may or may not penetrate the stratum corneum to any great degree, and they need to reach the dermis to be taken up by cells to have their effects.

"They don't last long," she said of the cosmeceutical peptides. "When you apply them on the skin, they go away rapidly. So they either don't penetrate or if they do, they may not have enough time or enough concentration to get to the target organs to make collagen."

Peptide-containing cosmeceuticals can also cost a lot, Dr. Fields said. StriVectin-SD, for example, costs about $135 for a 6-ounce tube when purchased from the manufacturer, and it contains palmitoyl pentapeptide as a reported active ingredient.

There is also little need for a patient interested in a skin rejuvenating regimen to use a peptide product because there are proven agents such as α-hydroxy acids and salicylic acid, and retinoids such as tretinoin and retinol.

Those are the agents she recommends to patients. "I love the old technology," she said.

If a patient does not tolerate a retinoid or one of the other older agents, she tells them to just use it twice a week to get started, rather than switch to a product that may be dubious. The patient can probably work up to using it more often.

LAS VEGAS — Dermatologists should tell their patients to be skeptical of "peptide" cosmeceuticals and to stick with proven agents, Dr. Kathy A. Fields said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Agents such as palmitoyl pentapeptide-3 have been shown to stimulate collagen production in a skin culture, but as with so many cosmeceutical products, none of the peptides has been proven to be effective in a published clinical trial or has any compelling scientific data, said Dr. Fields, a dermatologist in San Francisco who is a coinventor of Proactiv Solution, the popular acne treatment, and has her own line of cosmeceuticals, Rodan + Fields.

The peptides in cosmeceuticals may or may not penetrate the stratum corneum to any great degree, and they need to reach the dermis to be taken up by cells to have their effects.

"They don't last long," she said of the cosmeceutical peptides. "When you apply them on the skin, they go away rapidly. So they either don't penetrate or if they do, they may not have enough time or enough concentration to get to the target organs to make collagen."

Peptide-containing cosmeceuticals can also cost a lot, Dr. Fields said. StriVectin-SD, for example, costs about $135 for a 6-ounce tube when purchased from the manufacturer, and it contains palmitoyl pentapeptide as a reported active ingredient.

There is also little need for a patient interested in a skin rejuvenating regimen to use a peptide product because there are proven agents such as α-hydroxy acids and salicylic acid, and retinoids such as tretinoin and retinol.

Those are the agents she recommends to patients. "I love the old technology," she said.

If a patient does not tolerate a retinoid or one of the other older agents, she tells them to just use it twice a week to get started, rather than switch to a product that may be dubious. The patient can probably work up to using it more often.

LAS VEGAS — Dermatologists should tell their patients to be skeptical of "peptide" cosmeceuticals and to stick with proven agents, Dr. Kathy A. Fields said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Agents such as palmitoyl pentapeptide-3 have been shown to stimulate collagen production in a skin culture, but as with so many cosmeceutical products, none of the peptides has been proven to be effective in a published clinical trial or has any compelling scientific data, said Dr. Fields, a dermatologist in San Francisco who is a coinventor of Proactiv Solution, the popular acne treatment, and has her own line of cosmeceuticals, Rodan + Fields.

The peptides in cosmeceuticals may or may not penetrate the stratum corneum to any great degree, and they need to reach the dermis to be taken up by cells to have their effects.

"They don't last long," she said of the cosmeceutical peptides. "When you apply them on the skin, they go away rapidly. So they either don't penetrate or if they do, they may not have enough time or enough concentration to get to the target organs to make collagen."

Peptide-containing cosmeceuticals can also cost a lot, Dr. Fields said. StriVectin-SD, for example, costs about $135 for a 6-ounce tube when purchased from the manufacturer, and it contains palmitoyl pentapeptide as a reported active ingredient.

There is also little need for a patient interested in a skin rejuvenating regimen to use a peptide product because there are proven agents such as α-hydroxy acids and salicylic acid, and retinoids such as tretinoin and retinol.

Those are the agents she recommends to patients. "I love the old technology," she said.

If a patient does not tolerate a retinoid or one of the other older agents, she tells them to just use it twice a week to get started, rather than switch to a product that may be dubious. The patient can probably work up to using it more often.

Recent months have had a raft of bad news about injection lipolysis. Two prominent medical spas whose business was providing the popular treatments abruptly closed their doors, leaving patients in the lurch. Then, the Kansas Board of Healing Arts took action to strictly control the practice, a few months after trying to ban it.

Dr. Joel Schlessinger, immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, warned the society that lipolysis might be neither effective nor safe, and he urged society members not to practice lipolysis until the ingredients used in the injections become Food and Drug Administration approved.

Recent news articles about this increasingly practiced treatment, popularly known as Lipodissolve, have tended to focus on individuals who complain of having permanent nodules or indentations from the procedure or who tell of rushing to the emergency department.

On the Web site www.realself.com

The Web site reported that an analysis of the IP addresses of the reviewers showed that many of the positive reviews came from one of the two now-defunct companies, Go Fig Inc., without the authors identifying themselves, and some came from MedSculpt (both companies are now out of business).

But while agreeing that better regulation might be a good idea, physicians who perform the procedure think that their experience and studies suggest the risks of complications are quite low and the results, in properly selected patients, generally good.

Support for Mesotherapy

"Injection lipolysis is not without risk, but it is pretty darn safe," said Dr. Thomas Wright, an internist who has a cosmetic practice in suburban St. Louis. He has been collecting reports of cases and complications from members of the American Society of Nonsurgical Aesthetics.

In reviewing about 200,000 treatment cases either reported to him or that he has sought out, he has found only 2 definite cases in which there was a serious complication. Both were cases of skin ulceration at or near sites of injection that needed skin graft repair. Overall, he said that he has found about 20 cases of skin breakdown or a pigment change, though some of those were extremely small, a millimeter in size.

He reported having recorded no other confirmed complications.

"We've been using injection lipolysis in my clinic for 2 years now and getting excellent results," said Dr. Charles E. Crutchfield III, a dermatologist who practices in Minneapolis.

Dr. Crutchfield said the only serious complications he has seen or heard of are cases of skin ulceration. It is thought ulceration happens because of injections placed too superficially.

Dr. Crutchfield is a member of the medical advisory board of the American Society of Aesthetic Lipodissolve, a professional organization that owns a copyright on the term Lipodissolve and provides training in the procedure. Dr. Wright is also a medical advisory board member with the group.

Reports of Complications Conflict

Andrew Noel, a photographer from Las Vegas, had treatments at a Go Fig spa, and he said that 4 months after his last treatment, he still has welts "the size of 50-cent pieces" on his abdomen where he received the injections.

"My tummy is disfigured and I am steaming mad," he said.

Dr. Alastair Carruthers, a dermatologist in Vancouver, B.C., has seen two patients who had complications presumed to be from Lipodissolve treatments, the first in a woman who was injected in her lower eyelids and the second in a woman injected in her thighs.

The second woman developed significant ulceration that caused scarring, Dr. Carruthers said.

Dr. Elizabeth Tanzi, a dermatologist in practice in Washington, has seen four patients with complications from Lipodissolve treatment, two with "an unnatural firmness" that resolved only slowly, one with a vascular pattern over the treated area that lasted for a year and required laser treatment, and another patient who had a draining nodule.

But surveys, like Dr. Wright's, of physicians who practice injection lipolysis suggest that the procedure—while sometimes causing discomfort and leaving temporary nodules in treated areas that resolve over time—only rarely has complications.

And another survey of 75 practitioners reported that among 17,376 patients treated there were no hospitalizations, no deaths, and no cases of skin necrosis (Aesthetic Surg. J. 2006;26:575–85). Moreover, less than 1% of patients reported to their physicians pain that lasted beyond 2 weeks, and the most common complaint of patients was a less than desired result, reported for 12% of patients. Nineteen of the practitioners reported having seen hyperpigmentation, but in the majority of cases this resolved within 3 months.

Safety Concerns

Another of the concerns with lipolysis treatment is whether there might be long-term effects from phosphatidylcholine or sodium deoxycholate, or acute problems from exposure to those ingredients or from the release of so much fat at once.

The substances are both naturally present in the human body already, and used the way they are to reduce fat, have only "relatively benign, localized effects," said Dr. Adam Rotunda, a physician who now works as a medical director of research and development at Allergan Inc., but who conducted research on injection lipolysis as a dermatology resident at the University of California, Los Angeles.

Dr. Rotunda has a patent for a formulation of sodium deoxycholate (licensed to Kythera Biopharmaceuticals Inc.) alone for injection lipolysis, which he claims might be as effective as the phosphatidylcholine/sodium deoxycholate combination. That formulation is at present in clinical trials. Dr. Rotunda has no financial interest in the product, though he has received consulting fees from Kythera. The licensing fees are paid to the University of California, Los Angeles, he disclosed.

A Flawed Business Plan?

Dr. Wright said he is very familiar with one of the now-defunct companies, Fig, which was based in the St. Louis area. He is not only well acquainted with the former principals in the company, but he has treated about 30 former Fig patients. And he suggests that many of the complaints and complications being reported about injection lipolysis come from Fig clients, who were guaranteed results or a refund.

The company often had no physician onsite at its locations and many sometimes used doses too high and treated inappropriate patients. Dr. Wright recalled one patient who went to a Fig location every month for a year to be treated and never once saw a physician.

"The company was selling to inappropriate candidates and overselling," he said.

Many Fig patients that Dr. Wright said he treated were extremely overweight, and the proper candidate for lipolysis is one who is not overweight but simply has a localized area with a small amount of fat they would like to be rid of. Fig—which had 18 locations in various states—ceased its operations in December and filed for chapter 11 bankruptcy in January. The other prominent company that recently closed was MedSculpt, a firm with locations in Rockville, Md., and Fairfax, Va., which went into receivership in January.

Officials from both companies were unavailable for comment, and physicians connected with the companies either declined to comment or did not return calls and e-mails. However, in statements, Fig representatives said their investors pulled funding, and blamed the situation in part on a downturn in customers and bad press. MedSculpt needed a cash infusion and had investors lined up, but when Fig closed those investors balked, the representatives claim.

Recent Studies

Two studies have looked at whether the treatment has any identifiable systemic effects, and neither found any, said Dr. Rotunda. "We don't have the quality of data we need, but what we do have is pretty reassuring."

Brazilian investigators treated 30 patients with a series of four sessions of abdominal injections of sodium deoxycholate and looked at the local and systemic effects. At different time periods—ranging from 2 hours after an injection to 12 weeks—they measured lipids and kidney and liver function and found no significant changes (Dermatol. Surg. 2007;33:178–89).

In his own work, Dr. Rotunda has found that injecting phosphatidylcholine and sodium deoxycholate can produce changes in muscle architecture but the substances have to be injected directly into the muscles (Dermatol. Surg. 2004;30:1001–8).

Patients can experience nausea from the procedure, but that appears to be a cholinergic effect that occurs when too high a dose is used, he said.

Currently the evidence of the efficacy of injection lipolysis is anecdotal. But in November, a clinical trial of the combination solution got underway, sponsored by the Aesthetic Surgery Education and Research Foundation, run by Dr. V. Leroy Young, a former professor of plastic and reconstructive surgery at Washington University, St. Louis, who is now in private practice. The trial will enroll 20 subjects, who will be followed for 46 weeks.

In the meantime, both Dr. Crutchfield and Dr. Wright said they would have no problem if the FDA or some other agency came to regulate lipolysis procedures or the compounded ingredients used.

But Dr. Crutchfield also noted that injection lipolysis is not the first cosmetic product to be used off-label, and he cited Botox as an example. Botox was used cosmetically before its approval and currently is used in locations where it is not approved.

"If you are going to talk about this lacking FDA approval as a reason physicians should not be doing it, you are going to have to point the finger at everybody who does Botox," Dr. Crutchfield said.

Lipolysis has grown in popularity, while at the same time, a number of groups have expressed concern that it has no Food and Drug Administration approval, and have issued warnings about the procedure, saying there is no good clinical trial data to affirm benefit from the procedure and safety is not established.

Lipolysis may be neither safe nor effective, and shouldn't be used until approved by the FDA. DR. SCHLESSINGER

Ihave seen two patients who have had complications presumed to be from Lipodissolve treatments. DR. CARRUTHERS

Recent months have had a raft of bad news about injection lipolysis. Two prominent medical spas whose business was providing the popular treatments abruptly closed their doors, leaving patients in the lurch. Then, the Kansas Board of Healing Arts took action to strictly control the practice, a few months after trying to ban it.

Dr. Joel Schlessinger, immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, warned the society that lipolysis might be neither effective nor safe, and he urged society members not to practice lipolysis until the ingredients used in the injections become Food and Drug Administration approved.

Recent news articles about this increasingly practiced treatment, popularly known as Lipodissolve, have tended to focus on individuals who complain of having permanent nodules or indentations from the procedure or who tell of rushing to the emergency department.

On the Web site www.realself.com

The Web site reported that an analysis of the IP addresses of the reviewers showed that many of the positive reviews came from one of the two now-defunct companies, Go Fig Inc., without the authors identifying themselves, and some came from MedSculpt (both companies are now out of business).

But while agreeing that better regulation might be a good idea, physicians who perform the procedure think that their experience and studies suggest the risks of complications are quite low and the results, in properly selected patients, generally good.

Support for Mesotherapy

"Injection lipolysis is not without risk, but it is pretty darn safe," said Dr. Thomas Wright, an internist who has a cosmetic practice in suburban St. Louis. He has been collecting reports of cases and complications from members of the American Society of Nonsurgical Aesthetics.

In reviewing about 200,000 treatment cases either reported to him or that he has sought out, he has found only 2 definite cases in which there was a serious complication. Both were cases of skin ulceration at or near sites of injection that needed skin graft repair. Overall, he said that he has found about 20 cases of skin breakdown or a pigment change, though some of those were extremely small, a millimeter in size.

He reported having recorded no other confirmed complications.

"We've been using injection lipolysis in my clinic for 2 years now and getting excellent results," said Dr. Charles E. Crutchfield III, a dermatologist who practices in Minneapolis.

Dr. Crutchfield said the only serious complications he has seen or heard of are cases of skin ulceration. It is thought ulceration happens because of injections placed too superficially.

Dr. Crutchfield is a member of the medical advisory board of the American Society of Aesthetic Lipodissolve, a professional organization that owns a copyright on the term Lipodissolve and provides training in the procedure. Dr. Wright is also a medical advisory board member with the group.

Reports of Complications Conflict

Andrew Noel, a photographer from Las Vegas, had treatments at a Go Fig spa, and he said that 4 months after his last treatment, he still has welts "the size of 50-cent pieces" on his abdomen where he received the injections.

"My tummy is disfigured and I am steaming mad," he said.

Dr. Alastair Carruthers, a dermatologist in Vancouver, B.C., has seen two patients who had complications presumed to be from Lipodissolve treatments, the first in a woman who was injected in her lower eyelids and the second in a woman injected in her thighs.

The second woman developed significant ulceration that caused scarring, Dr. Carruthers said.

Dr. Elizabeth Tanzi, a dermatologist in practice in Washington, has seen four patients with complications from Lipodissolve treatment, two with "an unnatural firmness" that resolved only slowly, one with a vascular pattern over the treated area that lasted for a year and required laser treatment, and another patient who had a draining nodule.

But surveys, like Dr. Wright's, of physicians who practice injection lipolysis suggest that the procedure—while sometimes causing discomfort and leaving temporary nodules in treated areas that resolve over time—only rarely has complications.

And another survey of 75 practitioners reported that among 17,376 patients treated there were no hospitalizations, no deaths, and no cases of skin necrosis (Aesthetic Surg. J. 2006;26:575–85). Moreover, less than 1% of patients reported to their physicians pain that lasted beyond 2 weeks, and the most common complaint of patients was a less than desired result, reported for 12% of patients. Nineteen of the practitioners reported having seen hyperpigmentation, but in the majority of cases this resolved within 3 months.

Safety Concerns

Another of the concerns with lipolysis treatment is whether there might be long-term effects from phosphatidylcholine or sodium deoxycholate, or acute problems from exposure to those ingredients or from the release of so much fat at once.

The substances are both naturally present in the human body already, and used the way they are to reduce fat, have only "relatively benign, localized effects," said Dr. Adam Rotunda, a physician who now works as a medical director of research and development at Allergan Inc., but who conducted research on injection lipolysis as a dermatology resident at the University of California, Los Angeles.

Dr. Rotunda has a patent for a formulation of sodium deoxycholate (licensed to Kythera Biopharmaceuticals Inc.) alone for injection lipolysis, which he claims might be as effective as the phosphatidylcholine/sodium deoxycholate combination. That formulation is at present in clinical trials. Dr. Rotunda has no financial interest in the product, though he has received consulting fees from Kythera. The licensing fees are paid to the University of California, Los Angeles, he disclosed.

A Flawed Business Plan?

Dr. Wright said he is very familiar with one of the now-defunct companies, Fig, which was based in the St. Louis area. He is not only well acquainted with the former principals in the company, but he has treated about 30 former Fig patients. And he suggests that many of the complaints and complications being reported about injection lipolysis come from Fig clients, who were guaranteed results or a refund.

The company often had no physician onsite at its locations and many sometimes used doses too high and treated inappropriate patients. Dr. Wright recalled one patient who went to a Fig location every month for a year to be treated and never once saw a physician.

"The company was selling to inappropriate candidates and overselling," he said.

Many Fig patients that Dr. Wright said he treated were extremely overweight, and the proper candidate for lipolysis is one who is not overweight but simply has a localized area with a small amount of fat they would like to be rid of. Fig—which had 18 locations in various states—ceased its operations in December and filed for chapter 11 bankruptcy in January. The other prominent company that recently closed was MedSculpt, a firm with locations in Rockville, Md., and Fairfax, Va., which went into receivership in January.

Officials from both companies were unavailable for comment, and physicians connected with the companies either declined to comment or did not return calls and e-mails. However, in statements, Fig representatives said their investors pulled funding, and blamed the situation in part on a downturn in customers and bad press. MedSculpt needed a cash infusion and had investors lined up, but when Fig closed those investors balked, the representatives claim.

Recent Studies

Two studies have looked at whether the treatment has any identifiable systemic effects, and neither found any, said Dr. Rotunda. "We don't have the quality of data we need, but what we do have is pretty reassuring."

Brazilian investigators treated 30 patients with a series of four sessions of abdominal injections of sodium deoxycholate and looked at the local and systemic effects. At different time periods—ranging from 2 hours after an injection to 12 weeks—they measured lipids and kidney and liver function and found no significant changes (Dermatol. Surg. 2007;33:178–89).

In his own work, Dr. Rotunda has found that injecting phosphatidylcholine and sodium deoxycholate can produce changes in muscle architecture but the substances have to be injected directly into the muscles (Dermatol. Surg. 2004;30:1001–8).

Patients can experience nausea from the procedure, but that appears to be a cholinergic effect that occurs when too high a dose is used, he said.

Currently the evidence of the efficacy of injection lipolysis is anecdotal. But in November, a clinical trial of the combination solution got underway, sponsored by the Aesthetic Surgery Education and Research Foundation, run by Dr. V. Leroy Young, a former professor of plastic and reconstructive surgery at Washington University, St. Louis, who is now in private practice. The trial will enroll 20 subjects, who will be followed for 46 weeks.

In the meantime, both Dr. Crutchfield and Dr. Wright said they would have no problem if the FDA or some other agency came to regulate lipolysis procedures or the compounded ingredients used.

But Dr. Crutchfield also noted that injection lipolysis is not the first cosmetic product to be used off-label, and he cited Botox as an example. Botox was used cosmetically before its approval and currently is used in locations where it is not approved.

"If you are going to talk about this lacking FDA approval as a reason physicians should not be doing it, you are going to have to point the finger at everybody who does Botox," Dr. Crutchfield said.

Lipolysis has grown in popularity, while at the same time, a number of groups have expressed concern that it has no Food and Drug Administration approval, and have issued warnings about the procedure, saying there is no good clinical trial data to affirm benefit from the procedure and safety is not established.

Lipolysis may be neither safe nor effective, and shouldn't be used until approved by the FDA. DR. SCHLESSINGER

Ihave seen two patients who have had complications presumed to be from Lipodissolve treatments. DR. CARRUTHERS

Recent months have had a raft of bad news about injection lipolysis. Two prominent medical spas whose business was providing the popular treatments abruptly closed their doors, leaving patients in the lurch. Then, the Kansas Board of Healing Arts took action to strictly control the practice, a few months after trying to ban it.

Dr. Joel Schlessinger, immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, warned the society that lipolysis might be neither effective nor safe, and he urged society members not to practice lipolysis until the ingredients used in the injections become Food and Drug Administration approved.

Recent news articles about this increasingly practiced treatment, popularly known as Lipodissolve, have tended to focus on individuals who complain of having permanent nodules or indentations from the procedure or who tell of rushing to the emergency department.

On the Web site www.realself.com

The Web site reported that an analysis of the IP addresses of the reviewers showed that many of the positive reviews came from one of the two now-defunct companies, Go Fig Inc., without the authors identifying themselves, and some came from MedSculpt (both companies are now out of business).

But while agreeing that better regulation might be a good idea, physicians who perform the procedure think that their experience and studies suggest the risks of complications are quite low and the results, in properly selected patients, generally good.

Support for Mesotherapy

"Injection lipolysis is not without risk, but it is pretty darn safe," said Dr. Thomas Wright, an internist who has a cosmetic practice in suburban St. Louis. He has been collecting reports of cases and complications from members of the American Society of Nonsurgical Aesthetics.

In reviewing about 200,000 treatment cases either reported to him or that he has sought out, he has found only 2 definite cases in which there was a serious complication. Both were cases of skin ulceration at or near sites of injection that needed skin graft repair. Overall, he said that he has found about 20 cases of skin breakdown or a pigment change, though some of those were extremely small, a millimeter in size.

He reported having recorded no other confirmed complications.

"We've been using injection lipolysis in my clinic for 2 years now and getting excellent results," said Dr. Charles E. Crutchfield III, a dermatologist who practices in Minneapolis.

Dr. Crutchfield said the only serious complications he has seen or heard of are cases of skin ulceration. It is thought ulceration happens because of injections placed too superficially.

Dr. Crutchfield is a member of the medical advisory board of the American Society of Aesthetic Lipodissolve, a professional organization that owns a copyright on the term Lipodissolve and provides training in the procedure. Dr. Wright is also a medical advisory board member with the group.

Reports of Complications Conflict

Andrew Noel, a photographer from Las Vegas, had treatments at a Go Fig spa, and he said that 4 months after his last treatment, he still has welts "the size of 50-cent pieces" on his abdomen where he received the injections.

"My tummy is disfigured and I am steaming mad," he said.

Dr. Alastair Carruthers, a dermatologist in Vancouver, B.C., has seen two patients who had complications presumed to be from Lipodissolve treatments, the first in a woman who was injected in her lower eyelids and the second in a woman injected in her thighs.

The second woman developed significant ulceration that caused scarring, Dr. Carruthers said.

Dr. Elizabeth Tanzi, a dermatologist in practice in Washington, has seen four patients with complications from Lipodissolve treatment, two with "an unnatural firmness" that resolved only slowly, one with a vascular pattern over the treated area that lasted for a year and required laser treatment, and another patient who had a draining nodule.

But surveys, like Dr. Wright's, of physicians who practice injection lipolysis suggest that the procedure—while sometimes causing discomfort and leaving temporary nodules in treated areas that resolve over time—only rarely has complications.

And another survey of 75 practitioners reported that among 17,376 patients treated there were no hospitalizations, no deaths, and no cases of skin necrosis (Aesthetic Surg. J. 2006;26:575–85). Moreover, less than 1% of patients reported to their physicians pain that lasted beyond 2 weeks, and the most common complaint of patients was a less than desired result, reported for 12% of patients. Nineteen of the practitioners reported having seen hyperpigmentation, but in the majority of cases this resolved within 3 months.

Safety Concerns

Another of the concerns with lipolysis treatment is whether there might be long-term effects from phosphatidylcholine or sodium deoxycholate, or acute problems from exposure to those ingredients or from the release of so much fat at once.

The substances are both naturally present in the human body already, and used the way they are to reduce fat, have only "relatively benign, localized effects," said Dr. Adam Rotunda, a physician who now works as a medical director of research and development at Allergan Inc., but who conducted research on injection lipolysis as a dermatology resident at the University of California, Los Angeles.

Dr. Rotunda has a patent for a formulation of sodium deoxycholate (licensed to Kythera Biopharmaceuticals Inc.) alone for injection lipolysis, which he claims might be as effective as the phosphatidylcholine/sodium deoxycholate combination. That formulation is at present in clinical trials. Dr. Rotunda has no financial interest in the product, though he has received consulting fees from Kythera. The licensing fees are paid to the University of California, Los Angeles, he disclosed.

A Flawed Business Plan?

Dr. Wright said he is very familiar with one of the now-defunct companies, Fig, which was based in the St. Louis area. He is not only well acquainted with the former principals in the company, but he has treated about 30 former Fig patients. And he suggests that many of the complaints and complications being reported about injection lipolysis come from Fig clients, who were guaranteed results or a refund.

The company often had no physician onsite at its locations and many sometimes used doses too high and treated inappropriate patients. Dr. Wright recalled one patient who went to a Fig location every month for a year to be treated and never once saw a physician.

"The company was selling to inappropriate candidates and overselling," he said.

Many Fig patients that Dr. Wright said he treated were extremely overweight, and the proper candidate for lipolysis is one who is not overweight but simply has a localized area with a small amount of fat they would like to be rid of. Fig—which had 18 locations in various states—ceased its operations in December and filed for chapter 11 bankruptcy in January. The other prominent company that recently closed was MedSculpt, a firm with locations in Rockville, Md., and Fairfax, Va., which went into receivership in January.

Officials from both companies were unavailable for comment, and physicians connected with the companies either declined to comment or did not return calls and e-mails. However, in statements, Fig representatives said their investors pulled funding, and blamed the situation in part on a downturn in customers and bad press. MedSculpt needed a cash infusion and had investors lined up, but when Fig closed those investors balked, the representatives claim.

Recent Studies

Two studies have looked at whether the treatment has any identifiable systemic effects, and neither found any, said Dr. Rotunda. "We don't have the quality of data we need, but what we do have is pretty reassuring."

Brazilian investigators treated 30 patients with a series of four sessions of abdominal injections of sodium deoxycholate and looked at the local and systemic effects. At different time periods—ranging from 2 hours after an injection to 12 weeks—they measured lipids and kidney and liver function and found no significant changes (Dermatol. Surg. 2007;33:178–89).

In his own work, Dr. Rotunda has found that injecting phosphatidylcholine and sodium deoxycholate can produce changes in muscle architecture but the substances have to be injected directly into the muscles (Dermatol. Surg. 2004;30:1001–8).

Patients can experience nausea from the procedure, but that appears to be a cholinergic effect that occurs when too high a dose is used, he said.

Currently the evidence of the efficacy of injection lipolysis is anecdotal. But in November, a clinical trial of the combination solution got underway, sponsored by the Aesthetic Surgery Education and Research Foundation, run by Dr. V. Leroy Young, a former professor of plastic and reconstructive surgery at Washington University, St. Louis, who is now in private practice. The trial will enroll 20 subjects, who will be followed for 46 weeks.

In the meantime, both Dr. Crutchfield and Dr. Wright said they would have no problem if the FDA or some other agency came to regulate lipolysis procedures or the compounded ingredients used.

But Dr. Crutchfield also noted that injection lipolysis is not the first cosmetic product to be used off-label, and he cited Botox as an example. Botox was used cosmetically before its approval and currently is used in locations where it is not approved.

"If you are going to talk about this lacking FDA approval as a reason physicians should not be doing it, you are going to have to point the finger at everybody who does Botox," Dr. Crutchfield said.

Lipolysis has grown in popularity, while at the same time, a number of groups have expressed concern that it has no Food and Drug Administration approval, and have issued warnings about the procedure, saying there is no good clinical trial data to affirm benefit from the procedure and safety is not established.

Lipolysis may be neither safe nor effective, and shouldn't be used until approved by the FDA. DR. SCHLESSINGER

Ihave seen two patients who have had complications presumed to be from Lipodissolve treatments. DR. CARRUTHERS

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

CHICAGO — The clinical results of fractional skin resurfacing may be improved by pretreatment with an infrared laser or broadband infrared light source, according to a pilot study presented at the annual meeting of the American Society for Dermatologic Surgery.

"In the treatment of scars and wrinkles, combination deep heating immediately prior to fractional resurfacing gives better results in less time than fractional laser treatment alone," said Dr. Robert Weiss, of the dermatology department at Johns Hopkins University, Baltimore.

For this study, a control group of 20 patients received the usual fractional resurfacing on the face or neck with the Lux 1540 (Palomar Medical Technologies), while 20 others first received deep heating with an infrared pulsed laser using the 1,320-nm CoolTouch 3 (CoolTouch Inc.).

"Using the CoolTouch, we preheated the skin from a typical baseline temperature of 32° up to 40°, and then we applied the fractional resurfacing to the scar or wrinkle with the 1540-nm stamped mode at 50 mJ per little dot," Dr. Weiss said.

The control group received four monthly treatments, while the deep heating plus fractional group received two monthly treatments, he said, adding that the results were evaluated out to 3 months after the last treatment.

Down times caused by erythema ranged from 12 to 24 hours in the control group and increased to 48–96 hours for those receiving the combination treatment. That compares with 48–96 hours for patients who receive CO₂ laser fraction treatment, Dr. Weiss explained.

Pretreatment with heat produced both faster and visually better results, Dr. Weiss said, adding that, in some cases, two combination treatments improved scarring as much as five fractional-only treatments.

The investigators concluded that the combination treatment demonstrated a 30% improvement in scars and rhytids, compared with fractional only, and reduced the number of treatments from four to two.

Dr. Weiss is a consultant for Palomar and CoolTouch and performs research for Palomar, Cynosure, and CoolTouch.

LAS VEGAS — Porcine collagen crosslinked with D-ribose probably lasts as long or longer than does hyaluronic acid when used as a cosmetic filler for lips and nasolabial folds, Dr. Gary Monheit said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

The product, Evolence (Dermicol-P35) manufactured by ColBar LifeScience Ltd. (Israel), is approved for use in Europe and Canada and is expected to be approved in the United States, according to Dr. Monheit, principal investigator in the U.S. trial. The company has submitted an approval application to the Food and Drug Administration.

The trial's split-face design compared Evolence injection with hyaluronic acid (Restylane) injection in the nasolabial folds of 149 patients. After 6 months, there was no significant difference in the mean amount of correction the patients had on either side, as judged by study observers using the Modified Fitzpatrick Wrinkle Scale score (Dermatol. Surg. 2007;33:S213–21). Dr. Monheit disclosed receiving supplies and financial support from ColBar.

The secret to Evolence's longevity is thought to be the high level of crosslinking between the individual collagen fibers in the material, he said. "Because of this extra crosslinking, this is a very stable product that lasts over a year, possibly 2 years."

At 1-year follow-up, 90% of the patients that received Evolence still had some degree of improvement, said Dr. Monheit of the University of Alabama, Tuscaloosa. Evolence has been found to last up to 2 years when implanted into rabbit ears.

Raw material for Evolence comes from the tendons of pigs. In the first step of processing, the pig collagen's natural crosslinking is broken down by pepsin into monomeric collagen. Then the telopeptide of each collagen strand is removed because that part is the most immunogenic.

Pig collagen is used by ColBar because it is probably less immunogenic than beef collagen, he said.

Once the telopeptides are removed the material is again crosslinked, but instead of using glutaraldehyde or some other potentially problematic chemical to create the crosslinking, ColBar uses D-ribose, Dr. Monheit said.

LAS VEGAS — Porcine collagen crosslinked with D-ribose probably lasts as long or longer than does hyaluronic acid when used as a cosmetic filler for lips and nasolabial folds, Dr. Gary Monheit said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

The product, Evolence (Dermicol-P35) manufactured by ColBar LifeScience Ltd. (Israel), is approved for use in Europe and Canada and is expected to be approved in the United States, according to Dr. Monheit, principal investigator in the U.S. trial. The company has submitted an approval application to the Food and Drug Administration.

The trial's split-face design compared Evolence injection with hyaluronic acid (Restylane) injection in the nasolabial folds of 149 patients. After 6 months, there was no significant difference in the mean amount of correction the patients had on either side, as judged by study observers using the Modified Fitzpatrick Wrinkle Scale score (Dermatol. Surg. 2007;33:S213–21). Dr. Monheit disclosed receiving supplies and financial support from ColBar.

The secret to Evolence's longevity is thought to be the high level of crosslinking between the individual collagen fibers in the material, he said. "Because of this extra crosslinking, this is a very stable product that lasts over a year, possibly 2 years."

At 1-year follow-up, 90% of the patients that received Evolence still had some degree of improvement, said Dr. Monheit of the University of Alabama, Tuscaloosa. Evolence has been found to last up to 2 years when implanted into rabbit ears.

Raw material for Evolence comes from the tendons of pigs. In the first step of processing, the pig collagen's natural crosslinking is broken down by pepsin into monomeric collagen. Then the telopeptide of each collagen strand is removed because that part is the most immunogenic.

Pig collagen is used by ColBar because it is probably less immunogenic than beef collagen, he said.

Once the telopeptides are removed the material is again crosslinked, but instead of using glutaraldehyde or some other potentially problematic chemical to create the crosslinking, ColBar uses D-ribose, Dr. Monheit said.

LAS VEGAS — Porcine collagen crosslinked with D-ribose probably lasts as long or longer than does hyaluronic acid when used as a cosmetic filler for lips and nasolabial folds, Dr. Gary Monheit said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

The product, Evolence (Dermicol-P35) manufactured by ColBar LifeScience Ltd. (Israel), is approved for use in Europe and Canada and is expected to be approved in the United States, according to Dr. Monheit, principal investigator in the U.S. trial. The company has submitted an approval application to the Food and Drug Administration.

The trial's split-face design compared Evolence injection with hyaluronic acid (Restylane) injection in the nasolabial folds of 149 patients. After 6 months, there was no significant difference in the mean amount of correction the patients had on either side, as judged by study observers using the Modified Fitzpatrick Wrinkle Scale score (Dermatol. Surg. 2007;33:S213–21). Dr. Monheit disclosed receiving supplies and financial support from ColBar.

The secret to Evolence's longevity is thought to be the high level of crosslinking between the individual collagen fibers in the material, he said. "Because of this extra crosslinking, this is a very stable product that lasts over a year, possibly 2 years."

At 1-year follow-up, 90% of the patients that received Evolence still had some degree of improvement, said Dr. Monheit of the University of Alabama, Tuscaloosa. Evolence has been found to last up to 2 years when implanted into rabbit ears.

Raw material for Evolence comes from the tendons of pigs. In the first step of processing, the pig collagen's natural crosslinking is broken down by pepsin into monomeric collagen. Then the telopeptide of each collagen strand is removed because that part is the most immunogenic.

Pig collagen is used by ColBar because it is probably less immunogenic than beef collagen, he said.

Once the telopeptides are removed the material is again crosslinked, but instead of using glutaraldehyde or some other potentially problematic chemical to create the crosslinking, ColBar uses D-ribose, Dr. Monheit said.

Alaser system for skin rejuvenation that delivers ablative fractional resurfacing technology made its official debut at the annual meeting of the American Academy of Dermatology.

Manufactured by Mountain View, Calif.-based Reliant Technologies, the 10,600-nm CO₂ Fraxel re:pair laser uses a continuous motion handpiece to create microscopic "zones of treatment" evenly across the surface of the skin. Clinical studies have demonstrated that it can treat up to 6 g of dermal tissue in a single treatment session with depths that range from 300 mcm to 1.6 mm, according to the manufacturer.

In May of 2007 the device was cleared by the Food and Drug Administration for ablation, coagulation, and skin resurfacing. In December of 2007 it received FDA 510(k) clearance for the treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The current retail price of the Fraxel re:pair system is $129,000.

Studies of the device have included about 500 treatments over the last 2.5 years. In one recent study of its use on the forearm skin of 24 subjects with Fitzpatrick skin types II-IV, researchers tested pulse energies that ranged from 5 to 40 mJ and used hematoxylin and eosin to assess the legions histologically (Lasers Surg. Med. 2007;39:96–107). They found that changing the pulse energy from 5 to 30 mJ created a threefold increase in lesion depth and a twofold increase in width.

"Interestingly, ablative fractional resurfacing demonstrated much more rapid reepithelialization when compared to its nonfractional predecessors, whether powered by erbium or CO₂ lasers," reported the researchers (some of whom were employed by Reliant), led by Dr. Basil M. Hantash of Stanford (Calif.) University. "By 48 hours, most subjects demonstrated complete reepithelialization."

Subsequent studies of the system have used pulse energies that reach 70 mJ.

In an interview, one of the other study authors, Dr. Christopher Zachary, chair of the department of dermatology, University of California, Irvine, said that as long as physicians work within the recommended parameters, the Fraxel re:pair system "is going to give you a very predictable and reliable result and it's going to be much safer than the traditional carbon dioxide or erbium YAG lasers, which were associated with persistent redness, loss of pigmentation—which is delayed and permanent—scarring, and so forth."

In most cases, one treatment is sufficient and downtime is 2–4 days depending on the parameters used. "On day 5 you have redness and swelling," said Dr. Zachary, an unpaid consultant to Reliant Technologies.

Dr. Zachary said that he has limited experience using the device in dark-skinned patients, but "I absolutely intend to use it [on dark-skinned patients] on a regular basis," he said. "Darker skin types are going to have problems with skin pigmentation. To prevent it, we are pretreating for at least 2 weeks with a bleaching agent such as hydroquinone 4% cream, which will reside within the normal untreated skin after you have treated a fraction of the skin. That area that you do not treat will have a reservoir of hydroquinone which tends to prevent increased postinflammatory hyperpigmentation."

Trials are currently underway to study the use of the Fraxel re:pair system for treating acne scars, surgical scars, and striae. Dr. Zachary said that patients with severe acne scarring "are probably going to have two to three treatments separated by about a month each."

Dr. Robert A. Weiss, president-elect of the American Society for Dermatologic Surgery, called the Fraxel re:pair system an "elegant device" and noted that ablative fractional technology "is the next phase of fractional. It really does give a lot more improvement."

Dr. Weiss, who practices in Hunt Valley, Md., said that he currently uses a competing fractional laser procedure from Lumenis Ltd. called ActiveFX, which is delivered by the company's UltraCool Encore CO₂ system. Dr. Weiss is a member of the medical advisory board for Lumenis Ltd.

Dr. Zachary disclosed that he has received equipment and honoraria from Reliant Technologies and that he serves as a consultant for other laser companies.

A patient is shown before (left) and 1 month after treatment with the Fraxel re:pair laser, which is said to demonstrate "more rapid reepithelialization." Photos courtesy Dr. Zakia Rahman

Alaser system for skin rejuvenation that delivers ablative fractional resurfacing technology made its official debut at the annual meeting of the American Academy of Dermatology.

Manufactured by Mountain View, Calif.-based Reliant Technologies, the 10,600-nm CO₂ Fraxel re:pair laser uses a continuous motion handpiece to create microscopic "zones of treatment" evenly across the surface of the skin. Clinical studies have demonstrated that it can treat up to 6 g of dermal tissue in a single treatment session with depths that range from 300 mcm to 1.6 mm, according to the manufacturer.

In May of 2007 the device was cleared by the Food and Drug Administration for ablation, coagulation, and skin resurfacing. In December of 2007 it received FDA 510(k) clearance for the treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The current retail price of the Fraxel re:pair system is $129,000.

Studies of the device have included about 500 treatments over the last 2.5 years. In one recent study of its use on the forearm skin of 24 subjects with Fitzpatrick skin types II-IV, researchers tested pulse energies that ranged from 5 to 40 mJ and used hematoxylin and eosin to assess the legions histologically (Lasers Surg. Med. 2007;39:96–107). They found that changing the pulse energy from 5 to 30 mJ created a threefold increase in lesion depth and a twofold increase in width.

"Interestingly, ablative fractional resurfacing demonstrated much more rapid reepithelialization when compared to its nonfractional predecessors, whether powered by erbium or CO₂ lasers," reported the researchers (some of whom were employed by Reliant), led by Dr. Basil M. Hantash of Stanford (Calif.) University. "By 48 hours, most subjects demonstrated complete reepithelialization."

Subsequent studies of the system have used pulse energies that reach 70 mJ.

In an interview, one of the other study authors, Dr. Christopher Zachary, chair of the department of dermatology, University of California, Irvine, said that as long as physicians work within the recommended parameters, the Fraxel re:pair system "is going to give you a very predictable and reliable result and it's going to be much safer than the traditional carbon dioxide or erbium YAG lasers, which were associated with persistent redness, loss of pigmentation—which is delayed and permanent—scarring, and so forth."

In most cases, one treatment is sufficient and downtime is 2–4 days depending on the parameters used. "On day 5 you have redness and swelling," said Dr. Zachary, an unpaid consultant to Reliant Technologies.

Dr. Zachary said that he has limited experience using the device in dark-skinned patients, but "I absolutely intend to use it [on dark-skinned patients] on a regular basis," he said. "Darker skin types are going to have problems with skin pigmentation. To prevent it, we are pretreating for at least 2 weeks with a bleaching agent such as hydroquinone 4% cream, which will reside within the normal untreated skin after you have treated a fraction of the skin. That area that you do not treat will have a reservoir of hydroquinone which tends to prevent increased postinflammatory hyperpigmentation."

Trials are currently underway to study the use of the Fraxel re:pair system for treating acne scars, surgical scars, and striae. Dr. Zachary said that patients with severe acne scarring "are probably going to have two to three treatments separated by about a month each."

Dr. Robert A. Weiss, president-elect of the American Society for Dermatologic Surgery, called the Fraxel re:pair system an "elegant device" and noted that ablative fractional technology "is the next phase of fractional. It really does give a lot more improvement."

Dr. Weiss, who practices in Hunt Valley, Md., said that he currently uses a competing fractional laser procedure from Lumenis Ltd. called ActiveFX, which is delivered by the company's UltraCool Encore CO₂ system. Dr. Weiss is a member of the medical advisory board for Lumenis Ltd.

Dr. Zachary disclosed that he has received equipment and honoraria from Reliant Technologies and that he serves as a consultant for other laser companies.

A patient is shown before (left) and 1 month after treatment with the Fraxel re:pair laser, which is said to demonstrate "more rapid reepithelialization." Photos courtesy Dr. Zakia Rahman

Alaser system for skin rejuvenation that delivers ablative fractional resurfacing technology made its official debut at the annual meeting of the American Academy of Dermatology.

Manufactured by Mountain View, Calif.-based Reliant Technologies, the 10,600-nm CO₂ Fraxel re:pair laser uses a continuous motion handpiece to create microscopic "zones of treatment" evenly across the surface of the skin. Clinical studies have demonstrated that it can treat up to 6 g of dermal tissue in a single treatment session with depths that range from 300 mcm to 1.6 mm, according to the manufacturer.

In May of 2007 the device was cleared by the Food and Drug Administration for ablation, coagulation, and skin resurfacing. In December of 2007 it received FDA 510(k) clearance for the treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The current retail price of the Fraxel re:pair system is $129,000.

Studies of the device have included about 500 treatments over the last 2.5 years. In one recent study of its use on the forearm skin of 24 subjects with Fitzpatrick skin types II-IV, researchers tested pulse energies that ranged from 5 to 40 mJ and used hematoxylin and eosin to assess the legions histologically (Lasers Surg. Med. 2007;39:96–107). They found that changing the pulse energy from 5 to 30 mJ created a threefold increase in lesion depth and a twofold increase in width.

"Interestingly, ablative fractional resurfacing demonstrated much more rapid reepithelialization when compared to its nonfractional predecessors, whether powered by erbium or CO₂ lasers," reported the researchers (some of whom were employed by Reliant), led by Dr. Basil M. Hantash of Stanford (Calif.) University. "By 48 hours, most subjects demonstrated complete reepithelialization."

Subsequent studies of the system have used pulse energies that reach 70 mJ.

In an interview, one of the other study authors, Dr. Christopher Zachary, chair of the department of dermatology, University of California, Irvine, said that as long as physicians work within the recommended parameters, the Fraxel re:pair system "is going to give you a very predictable and reliable result and it's going to be much safer than the traditional carbon dioxide or erbium YAG lasers, which were associated with persistent redness, loss of pigmentation—which is delayed and permanent—scarring, and so forth."

In most cases, one treatment is sufficient and downtime is 2–4 days depending on the parameters used. "On day 5 you have redness and swelling," said Dr. Zachary, an unpaid consultant to Reliant Technologies.

Dr. Zachary said that he has limited experience using the device in dark-skinned patients, but "I absolutely intend to use it [on dark-skinned patients] on a regular basis," he said. "Darker skin types are going to have problems with skin pigmentation. To prevent it, we are pretreating for at least 2 weeks with a bleaching agent such as hydroquinone 4% cream, which will reside within the normal untreated skin after you have treated a fraction of the skin. That area that you do not treat will have a reservoir of hydroquinone which tends to prevent increased postinflammatory hyperpigmentation."

Trials are currently underway to study the use of the Fraxel re:pair system for treating acne scars, surgical scars, and striae. Dr. Zachary said that patients with severe acne scarring "are probably going to have two to three treatments separated by about a month each."

Dr. Robert A. Weiss, president-elect of the American Society for Dermatologic Surgery, called the Fraxel re:pair system an "elegant device" and noted that ablative fractional technology "is the next phase of fractional. It really does give a lot more improvement."

Dr. Weiss, who practices in Hunt Valley, Md., said that he currently uses a competing fractional laser procedure from Lumenis Ltd. called ActiveFX, which is delivered by the company's UltraCool Encore CO₂ system. Dr. Weiss is a member of the medical advisory board for Lumenis Ltd.

Dr. Zachary disclosed that he has received equipment and honoraria from Reliant Technologies and that he serves as a consultant for other laser companies.

A patient is shown before (left) and 1 month after treatment with the Fraxel re:pair laser, which is said to demonstrate "more rapid reepithelialization." Photos courtesy Dr. Zakia Rahman

The Food and Drug Administration has updated the information that is available on its Web site for consumers and health professionals on injectable fillers. In late January, the agency posted data on materials used; indications; risks; contraindications; and, for patients, questions to consider before they receive such an injection. The information is at www.fda.gov/cdrh/wrinklefillers

The Food and Drug Administration has updated the information that is available on its Web site for consumers and health professionals on injectable fillers. In late January, the agency posted data on materials used; indications; risks; contraindications; and, for patients, questions to consider before they receive such an injection. The information is at www.fda.gov/cdrh/wrinklefillers

The Food and Drug Administration has updated the information that is available on its Web site for consumers and health professionals on injectable fillers. In late January, the agency posted data on materials used; indications; risks; contraindications; and, for patients, questions to consider before they receive such an injection. The information is at www.fda.gov/cdrh/wrinklefillers

In treating cosmetic dermatology patients for symptoms associated with aging, procedures are not enough, Dr. Leslie Baumann said in a Galderma-sponsored symposium held during the 21st World Congress of Dermatology in Buenos Aires.

"Skin care is also important," she said. "When you think about skin rejuvenation, you need to think about all components." Combination therapy is a key to treating aging-related skin problems.

In the epidermis, pigmentary therapy targets the melanocytes, and "barrier-restoring therapy" targets the keratinocytes. "Skin needs to be hydrated to look young," said Dr. Baumann, director of cosmetic dermatology at the University of Miami.

As skin ages, the levels of collagen and glycosaminoglycans in the dermis decrease and alterations in elastic tissue occur, she noted. Injection of hyaluronic acid or collagen fillers helps restore the structural integrity of the dermis. Vascular therapy prevents the enlargement of blood vessels in the dermis that is seen in the blushing associated with rosacea. Volume-restoring therapy targets the adipocytes in the subcutaneous tissue, and therapy that controls muscular movements, such as botulinum toxin, targets muscle fibers.

Retinoids prevent skin aging by increasing the production of collagen and hyaluronic acid. "You are doing your patients a disservice to give them botulinum toxin or fillers and not give them a retinoid," said Dr. Baumann.

Nearly half of the cosmetic dermatologists interviewed in a recent market survey acknowledged discussing makeup with their patients. Surprisingly, only a slightly higher percentage of those surveyed talked to their patients about the use of retinoids in skin rejuvenation. "If we are going to talk to our patients about how to look better, we need to tell them about the science," she said. Cosmetic dermatologists should explain to their patients the scientific basis underpinning the use of retinoids in skin rejuvenation.

Tolerability appears to be a problem. "We're just not seeing a lot of retinoid use. I think it is because retinoids cause redness and flaking, and patients don't want to use them," she said. "Doctors don't have time to explain to the patients how to use retinoids properly and how to get through that initial redness."

Dr. Baumann recommends the use of topical retinoids for treatment of photoaging, acne, pigmentation disorders such as melasma and solar lentigos, and rosacea. All retinoids that affect the retinoic acid receptor are thought to improve photoaging, but only tretinoin and Avage (tazarotene, Allergan) are approved by the Food and Drug Administration for the treatment of photoaging, she said.

Photoaging leads not just to wrinkles, but also to sunspots and pigmentary damage. In her own practice, Dr. Baumann uses Tri-Luma cream (fluocinolone acetonide/hydroquinone/tretinoin, Galderma) off label for treatment of photoaging.

"I use retinoids in rosacea patients," she said. "I know you've been taught not to, but I put all my rosacea patients on retinoids. I can do it by teaching them how to use the retinoids properly."

Dr. Baumann is an investigator for Galderma and other manufacturers of skin care products.

In treating cosmetic dermatology patients for symptoms associated with aging, procedures are not enough, Dr. Leslie Baumann said in a Galderma-sponsored symposium held during the 21st World Congress of Dermatology in Buenos Aires.

"Skin care is also important," she said. "When you think about skin rejuvenation, you need to think about all components." Combination therapy is a key to treating aging-related skin problems.

In the epidermis, pigmentary therapy targets the melanocytes, and "barrier-restoring therapy" targets the keratinocytes. "Skin needs to be hydrated to look young," said Dr. Baumann, director of cosmetic dermatology at the University of Miami.

As skin ages, the levels of collagen and glycosaminoglycans in the dermis decrease and alterations in elastic tissue occur, she noted. Injection of hyaluronic acid or collagen fillers helps restore the structural integrity of the dermis. Vascular therapy prevents the enlargement of blood vessels in the dermis that is seen in the blushing associated with rosacea. Volume-restoring therapy targets the adipocytes in the subcutaneous tissue, and therapy that controls muscular movements, such as botulinum toxin, targets muscle fibers.

Retinoids prevent skin aging by increasing the production of collagen and hyaluronic acid. "You are doing your patients a disservice to give them botulinum toxin or fillers and not give them a retinoid," said Dr. Baumann.

Nearly half of the cosmetic dermatologists interviewed in a recent market survey acknowledged discussing makeup with their patients. Surprisingly, only a slightly higher percentage of those surveyed talked to their patients about the use of retinoids in skin rejuvenation. "If we are going to talk to our patients about how to look better, we need to tell them about the science," she said. Cosmetic dermatologists should explain to their patients the scientific basis underpinning the use of retinoids in skin rejuvenation.

Tolerability appears to be a problem. "We're just not seeing a lot of retinoid use. I think it is because retinoids cause redness and flaking, and patients don't want to use them," she said. "Doctors don't have time to explain to the patients how to use retinoids properly and how to get through that initial redness."

Dr. Baumann recommends the use of topical retinoids for treatment of photoaging, acne, pigmentation disorders such as melasma and solar lentigos, and rosacea. All retinoids that affect the retinoic acid receptor are thought to improve photoaging, but only tretinoin and Avage (tazarotene, Allergan) are approved by the Food and Drug Administration for the treatment of photoaging, she said.

Photoaging leads not just to wrinkles, but also to sunspots and pigmentary damage. In her own practice, Dr. Baumann uses Tri-Luma cream (fluocinolone acetonide/hydroquinone/tretinoin, Galderma) off label for treatment of photoaging.

"I use retinoids in rosacea patients," she said. "I know you've been taught not to, but I put all my rosacea patients on retinoids. I can do it by teaching them how to use the retinoids properly."

Dr. Baumann is an investigator for Galderma and other manufacturers of skin care products.

In treating cosmetic dermatology patients for symptoms associated with aging, procedures are not enough, Dr. Leslie Baumann said in a Galderma-sponsored symposium held during the 21st World Congress of Dermatology in Buenos Aires.

"Skin care is also important," she said. "When you think about skin rejuvenation, you need to think about all components." Combination therapy is a key to treating aging-related skin problems.

In the epidermis, pigmentary therapy targets the melanocytes, and "barrier-restoring therapy" targets the keratinocytes. "Skin needs to be hydrated to look young," said Dr. Baumann, director of cosmetic dermatology at the University of Miami.

As skin ages, the levels of collagen and glycosaminoglycans in the dermis decrease and alterations in elastic tissue occur, she noted. Injection of hyaluronic acid or collagen fillers helps restore the structural integrity of the dermis. Vascular therapy prevents the enlargement of blood vessels in the dermis that is seen in the blushing associated with rosacea. Volume-restoring therapy targets the adipocytes in the subcutaneous tissue, and therapy that controls muscular movements, such as botulinum toxin, targets muscle fibers.

Retinoids prevent skin aging by increasing the production of collagen and hyaluronic acid. "You are doing your patients a disservice to give them botulinum toxin or fillers and not give them a retinoid," said Dr. Baumann.

Nearly half of the cosmetic dermatologists interviewed in a recent market survey acknowledged discussing makeup with their patients. Surprisingly, only a slightly higher percentage of those surveyed talked to their patients about the use of retinoids in skin rejuvenation. "If we are going to talk to our patients about how to look better, we need to tell them about the science," she said. Cosmetic dermatologists should explain to their patients the scientific basis underpinning the use of retinoids in skin rejuvenation.

Tolerability appears to be a problem. "We're just not seeing a lot of retinoid use. I think it is because retinoids cause redness and flaking, and patients don't want to use them," she said. "Doctors don't have time to explain to the patients how to use retinoids properly and how to get through that initial redness."

Dr. Baumann recommends the use of topical retinoids for treatment of photoaging, acne, pigmentation disorders such as melasma and solar lentigos, and rosacea. All retinoids that affect the retinoic acid receptor are thought to improve photoaging, but only tretinoin and Avage (tazarotene, Allergan) are approved by the Food and Drug Administration for the treatment of photoaging, she said.

Photoaging leads not just to wrinkles, but also to sunspots and pigmentary damage. In her own practice, Dr. Baumann uses Tri-Luma cream (fluocinolone acetonide/hydroquinone/tretinoin, Galderma) off label for treatment of photoaging.

"I use retinoids in rosacea patients," she said. "I know you've been taught not to, but I put all my rosacea patients on retinoids. I can do it by teaching them how to use the retinoids properly."

Dr. Baumann is an investigator for Galderma and other manufacturers of skin care products.