Aesthetic Dermatology

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

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

PHOENIX — California Governor Arnold Schwarzenegger signed a bill into law that raises public awareness about the risks of cosmetic surgery and targets the aggressive marketing of services that make the risks “seem almost nonexistent,” California State Assemblywoman Wilmer Amina Carter said.

Known also as the “Donda West Act,” the law is named after Kanye West's mother, who died of complications following liposuction and mammaplasty. The law requires a physical examination 30 days before a patient undergoes a cosmetic surgery procedure.

“People may think they are well enough for cosmetic surgery, but [they] are not always,” said Ms. Carter, who introduced the legislation, known officially as AB 1116. She spoke at the joint annual meeting of American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology & Aesthetic Surgery.

Earlier this year the governor vetoed a second patient safety bill also sponsored by Ms. Carter. That legislation would have increased enforcement of patient safety laws specifically addressing medi-spa-based cosmetic procedures and laser hair removal retail chains.

“The bill made it through with only one 'no' vote before Governor Schwarzenegger vetoed it,” said Dr. Robert A. Weiss, a private practice dermatologist in Hunt Valley, Md.

“We're having budgetary issues in California, as are most states. The Governor is very adamant about getting things done, and is holding some bills hostage to get things he wants done,” Ms. Carter, who introduced the bill to the assembly, said. “It is not the fault of the bill—it's relevant.”

Known as AB 252, the bill aimed to increase penalties and enforcement related to existing California law that prohibits corporate medi-spas and hair removal chains from hiring medical directors who provide supervision in name only. If it had become law, the Medical Board of California would be authorized to remove the medical license of any physician who allowed his or her license to be used for a nonphysician to establish a medi-spa, commonly known as a “rent-a-doc” scheme. The ASDS and CalDerm co-sponsored the bill.

“There is a growing trend for elective cosmetic surgery but the public is not always aware of the risks,” Ms. Carter said. She cited the case of a patient treated at a medi-spa located on an upper floor of a mall. Something went wrong, and there was no doctor on site. Ambulance workers could not get the patient down through the mall and the patient had to be lowered through a window. “It's those kinds of things we have to protect patients from.”

“When I became an elected official, I decided one of my goals was to author legislation to protect our citizens from harm,” Ms. Carter said. She vowed to continue working on patient safety issues.

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

PHILADELPHIA — OnabotulinumtoxinA appears to be a safe, effective, and well-tolerated headache prophylactic for patients with chronic migraine.

Two large randomized controlled trials showed that the toxin significantly reduced migraine frequency and improved headache-related disability over a 24- week period, Dr. David W. Dodick reported at the International Headache Congress.

The studies—PREEMPT 1 and 2—were conducted at 22 centers in North America and Europe, and included 1,384 patients (average age 41 years). Each trial consisted of a 4-week baseline period, during which patients kept a daily headache diary, followed by 24 weeks of treatment during which patients received two injection cycles of either placebo or onabotulinum toxin A (Botox), which has not been approved by the Food and Drug Administration for migraine prophylaxis. From 24 to 56 weeks, there was an open-label trial consisting of three injection cycles of the study drug, said Dr. Dodick of the Mayo Clinic Arizona, Phoenix.

At baseline, patients reported a mean of 20 headache days per month, 19 of which were considered migraine days, with a mean of 290 cumulative headache hours. The mean score on the Headache Impact Test–6 (HIT-6) survey was 65, indicating severe impact. Most of the patients (93%) also reported severe headache-related disability, and 65% were overusing acute pain medications.

During the double-blind phase, patients randomized to the treatment group received two injection cycles (one every 12 weeks) of onabotulinumtoxinA 155 U.

The medication was injected at 31 sites across seven muscle areas in the head and neck. At the physicians' discretion, an additional 40 U could be injected among three additional muscle groups; the maximum dose was 195 U.

The study's main end point was frequency of headache days; secondary end points were frequency of migraine days, moderate/severe headache days, monthly headache hours, and proportion of patients with a severe HIT-6 score.

At 24 weeks, patients in the active group had a significantly greater reduction in head- ache days and migraine days than did those taking placebo (−8 vs. −6). The HIT-6 score also declined significantly more among the active group (−5 points vs. −2 points). Patients receiving the study drug had a greater decrease in cumulative headache hours per month (−120 vs. −80), and a lower proportion had a severe score on the HIT-6 survey (68% vs. 78%).

“The only outcome that was not statistically significantly better among the active group than the placebo group was the percentage overusing acute pain medications. However, the use of triptans did decrease significantly in the active group compared to the placebo group,” Dr. Dodick said at the congress, which was sponsored by the International Headache Society and the American Headache Society.

Adverse events occurred in 62% of those taking the study drug and 52% of those taking placebo—a significant difference, he said.

There were also significantly more treatment-related adverse events in the onabotulinumtoxinA group (29% vs. 13%). One serious treatment-related adverse event did occur in the active group—a severe postinjection migraine that required hospitalization.

Adverse events occurring in more than 5% of the entire study group were neck pain (9%) and upper respiratory infection (5%).

Four patients in the active group and one in the placebo group discontinued active injections because of an adverse event.

The study was sponsored by Allergan Inc., manufacturer of the study drug. Dr. Dodick reported having received honoraria from the company.

The Botox group had a significantly greater reduction in headache days and migraine days than did those taking placebo.

Source DR. DODICK

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

SAN FRANCISCO — Although changes to the aging face are often complex, knowing filler basics will help optimize results, Dr. Jason R. Michaels said.

“When I approach patients, I try to keep it as basic as possible: who, what, where, why, and when?” Dr. Michaels said. “It is almost back to the grammar lessons we had as kids.”

Even so, pairing the appropriate filler to each patient remains an art form. “Think of [fillers] as different types of paint brushes; and I choose depending on whether I want a broader effect or to treat more detail,” he said at a seminar on women's and pediatric dermatology sponsored by Skin Disease Education Foundation (SDEF).

“I tend to look at faces in four different categories: furrows, folds, shaping, and volume,” said Dr. Michaels, associate clinical professor of dermatology at the University of Nevada, Las Vegas.

For correction of furrows, for example, options include finer-gauge fillers such as CosmoDerm (INAMED Aesthetics), Prevelle Silk (Mentor), Juvéderm Ultra (Allergan), and Restylane (Medicis Aesthetics). These products are generally safe for injections higher up in the skin. “My ideal choice is CosmoDerm because it works great on fine lines and wrinkles, but the downside is it does not last as long as some others,” Dr. Michaels said. He is a consultant for Allergan and a consultant and speaker for Medicis.

For treating folds, “the world is your oyster,” Dr. Michaels said. Examples include CosmoPlast (INAMED Aesthetics), Elevess (Anika Therapeutics), and Evolence (Ortho Dermatologics). The majority of his patients are aged 25–55 years and filler studies typically include 18- to 65-year-olds. However, “I inject patients well into their 70s and beyond and some teenagers.” Juvéderm UltraPlus, Perlane (Medicis), and Radiesse (BioForm Medical) are among his preferred products for folds, particularly in older patients.

Like other enhancements, shaping with fillers is technique dependent. “This is the art of doing fillers—you are creating a shape, defining some characteristic the patient has,” said Dr. Michaels. He prefers CosmoPlast, Juvéderm Ultra, or Restylane for shaping.

Volume replacement “is about quantity, and you need lots of product,” Dr. Michaels said. “Think of volume fillers as the rug pad under a rug.” Evolence, Perlane, Radiesse, and Sculptra (Sanofi-Aventis) are among the options for volume. “The problem with Sculptra is delayed gratification, which is not necessary a bad thing—some patients do not want their friends to know they used a filler,” Dr. Michaels said.

Filler products can be used in combination, which “is taking this to a new level,” Dr. Michaels said. “It is not uncommon for me to use two or three different fillers on the same patient.” An example of a combination is Perlane injected into the low dermis, Restylane in the mid-dermis, and CosmoDerm in the high dermis.

“Its limitation, of course, is going to be cost. Not everyone can afford that,” Dr. Michaels said.

Dr. Michaels urged caution with injection of fillers superficially “unless you have a lot of experience.” Even with the best intentions, fillers do not always end up at the level a physician perceives, “although the outcomes are fine,” according to a histologic study of hyaluronic filler injections in 16 patients (Dermatol. Surg. 2008;34:S56–62).

SDEF and this news organization are owned by Elsevier.

Click here to see a video of Dr. Michaels explaining his strategy for patients on a budget and for use of filler combinations.

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — It may not be necessary to disclose all the potential risks of botulinum toxin that are listed in the black box warning on the label to cosmetic patients, said Dr. David J. Goldberg.

The final answer on how much disclosure is reasonable will likely come only as a result of future litigation, said Dr. Goldberg, director of laser research at Mount Sinai School of Medicine in New York.

"Err on the side of being conservative, but don't scare people with this entire black box warning," he said. "I would argue you have to take a practical approach." Dermatologists must disclose that the black box warning exists as part of the informed consent process, he said.

The Food and Drug Administration took action after the agency received reports of adverse events associated with the spread of the botulinum toxin beyond the local injection site. Unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, and loss of bladder control have been reported hours to weeks post injection. These sequelae occurred primarily in children with cerebral palsy treated off label to control muscle spasticity, he said.

The doses used for off-label indications "are often much higher" than the doses for approved uses, according to a statement released by the FDA.

The release states, in part: "For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label."

"You have to provide reasonable risks. I don't think you have to go down the road of bladder collapse. I don't mention death [during informed consent]. Your [cosmetic] patient is not likely to die," Dr. Goldberg said at a joint annual meeting of the American Society for Dermatologic Surgery (ASDS) and the American Society of Cosmetic Dermatology and Aesthetic Surgery. He said he had no relevant conflicts of interest.

"I was told we have to inform patients about all the risks on the black box warning," said Dr. Susan H. Weinkle, a Mohs surgeon and cosmetic dermatologist in private practice in Bradenton, Fla.

"Who told you that?" Dr. Goldberg asked.

"Several companies," replied Dr. Weinkle, who moderated the session at the meeting. She disclosed being a consultant for multiple companies, including Allergan Inc.

"The companies have to tell you that because the FDA requires them to. What is less clear is what is required of doctors," Dr. Goldberg said. He reiterated this lack of clarity exists because "there has been no litigation on this black box warning yet."

"I don't think it's reasonable to have to go through every one of those adverse events with them," he added. Protopic (tacrolimus) also has a black box warning. "Do you go over the … litany of all the [possible] adverse events every time you refill a prescription?"

'Provide reasonable risks. I don't think you have to go down the road of bladder collapse.'

Source DR. GOLDBERG

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

PHOENIX — Investigators found significant decreases in thigh circumference following multiple treatments with a dual-wavelength laser system with mechanical manipulation, compared with untreated thighs, in a multicenter study.

Dr. Michael H. Gold and his colleagues assessed 83 women 1 month after treatment with the SmoothShapes dual-energy laser and mechanical manipulation system (Elemé Medical Inc.). Each participant had one thigh selected randomly for treatment twice a week for 4 weeks, while their other thigh served as a control.

Significant reductions in circumference were noted at the upper, mid, and lower thigh, compared with baseline and the untreated thigh, at each assessment. “The SmoothShapes two-wavelength system was highly effective in producing thigh circumference reduction at each location and at each time point,” said Dr. Gold, who is in private practice in Nashville, Tenn., and is also with Vanderbilt University in Nashville. He is a consultant for Elemé Medical, which funded the study.

A total of 59 patients were considered responders (71%), and this group achieved a 3.5-cm average thigh circumference reduction at 1 month, Dr. Gold said at the joint annual meeting of the American Society for Dermatologic Surgery and the American Society of Cosmetic Dermatology and Aesthetic Surgery.

Mean circumference reductions on the treated thighs were “consistently, statistically significantly greater at all time points,” Dr. Gold said. “Three months' follow-up was also statistically significant.”

Investigators enrolled participants at one of five sites in the United States and one in France. The laser system features a 915-nm wavelength that liquefies fat. The device also has a 650-nm wavelength to increase fat cell membrane permeability. Contoured rollers then move liquefied lipids from the interstitial space to the lymphatic system for drainage, according to the manufacturer. The Food and Drug Administration cleared marketing of the device for the temporary reduction in the appearance of cellulite.

With laser and manipulation system treatment, reductions in thigh circumference were noted in patients at 1 month.

Source Photos courtesy Dr. Robert A. Weiss

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.

BETHESDA, MD. — A Food and Drug Administration advisory panel cast mixed votes on whether data on an injectable product derived from autologous fibroblast cells had demonstrated that it was safe and effective for treating moderate to severe nasolabial fold wrinkles in adults, the indication for which it is under review for approval.

At the meeting, the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted 11-3 that the data submitted by the manufacturer showed the product was effective in treating moderate to severe nasolabial fold wrinkles. Dr. Michael Olding, the panel's plastic surgeon and chief of plastic surgery at George Washington University, Washington, voted yes on the efficacy question, but emphasized that the indication was narrow and the product had not been shown to be effective in treating the nasolabial fold or contour deficiencies. He and the other panelists also said that they did not believe the agent had been shown to be effective in people over age 65 years, in nonwhite populations, or in older men, who were not well represented in the two pivotal trials. The efficacy had been seen primarily in white women under age 65 years, who accounted for most of the patients.

The panel also voted 8-6 that the data on the product, azfibrocel-T, had not demonstrated that it was safe for the indication, citing gaps in the data, including uncertainty over its mechanism of action and whether it induced scar formation or collagen production.

Other safety concerns included not knowing what happens to the fibroblasts over time and the lack of biopsies to help make that determination, as well as the lack of long-term data and the likelihood that, once approved, it would be widely used off-label, and there are no data to support other uses. The panel, however, did not appear overly concerned about the potential tumorigenicity of the product, although they said longer term data were needed to address this theoretical risk. The panel was not asked specifically whether to recommend approval.

The product, previously called Isolagen, was marketed commercially in the United States between 1995 and 1999 as a nonregulated product, and in the United Kingdom between 2002 and 2007. It is manufactured by Fibrocell Science Inc., which until August was Isolagen Technologies Inc. If approved, the product will be marketed as Laviv.

Azfibrocel-T is derived from fibroblasts obtained from three punch biopsies taken from behind the ear that are sent to a Fibrocell facility. Once there, they are isolated, harvested, prepared in an injectable cell suspension, frozen, and shipped to clinicians overnight, for use within 48 hours. The cells are harvested an average of 50 days after the biopsies, according to the company.

Treatment is administered in three doses at 5-week intervals and is injected with a 29-guage needle directly into the papillary dermis of the nasolabial fold wrinkles, where the fibroblasts “are believed to produce and organize extracellular matrix proteins, including collagen, by a mechanism analogous to natural wound healing,” according to the company.

In the two pivotal, identical U.S. multicenter, double-blind trials, a total of 421 patients were randomized to receive three injections of azfibrocel-T or vehicle to the nasolabial fold wrinkles. Patients' mean age was 56 years, and most were white women.

At 6 months after the first treatment, significantly more of the patients who received the active treatment evaluated themselves as having a 2-point improvement in a 5-point scale evaluating the appearance of the “lower part of their face,” when compared with those who had received the vehicle (57% and 46% of those who received azfibrocel-T in both studies, compared with 30% and 8%, respectively, among those in the vehicle groups). This was one of the two primary endpoints.

The second primary endpoint was a 2-point improvement on the Lemperle scale as assessed by a blinded evaluator's live assessment at the 6-month visit, using a photo guide of the scale. When enrolled, patients' wrinkles were at least a grade 3 (moderately deep) on the 6-point scale that ranges from 0 (no wrinkle) to 5.

The differences in evaluator assessments of the azfibrocel-T–treated patients and those who received the vehicle were not as wide as the patients' assessments, but were statistically significant. At 6 months, 33% of the patients in one study and 19% in the second study were evaluated as having a 2-point improvement, compared with 7% of those on the vehicle in both studies.

The most common adverse events associated with treatment were injection site reactions, namely erythema, swelling, bruising, and bleeding; these effects were mostly mild to moderate and did not last longer than 7–14 days. There was one case of a basal cell carcinoma near the injection site diagnosed 5 months after the third treatment. Clinical experience to date indicates the risk of scarring and keloids is minimal, according to the company, which has proposed plans for a mandatory physician training program.

Voting no on both efficacy and safety, panelist Dr. Lynn A. Drake of Harvard Medical School, Boston, said she was concerned about the lack of nonvisible evidence to support safety. She and other dermatologists on the panel said that it was important to determine whether normal or scar tissue was present after treatment, whether collagen was produced, and if so, what type, and whether elastin was affected.

Dr. Drake questioned whether the lack of efficacy in people over age 65 was indicative of the inability of the elderly to scar, and emphasized that once a new treatment for wrinkles becomes available, it is widely used immediately in all age groups and often in locations where it might not be safe.

If approved, azfibrocel-T would be the first cellular product for treating nasolabial fold wrinkles and the first fibroblast product contained in an injectable cell suspension, according to the FDA. It would be the second autologous cell product to be approved; the first is Carticel, a preparation of autologous chondrocytes used to repair knee cartilage. Clinical studies are underway in facial acne scars, gingival recession, and vocal fold scarring. A study in burn scars is being planned, the company said.

The FDA usually follows the recommendations of its advisory panels.