Aesthetic Dermatology

MONTREAL — Topical 5-fluorouracil used for the treatment of actinic keratosis can also promote dermal remodeling in photoaged skin, according to a small study.

For years, clinicians and patients have noted that, in addition to treating actinic keratosis (AK), topical 5-fluorouracil (5-FU) treatment can result in skin softening and smoothing, Dr. Sewon Kang of Johns Hopkins University, Baltimore, said at the annual meeting of the Society for Investigative Dermatology.

"We knew this anecdotally, but it had never been documented or studied at a molecular level," he said in an interview. "We did this study to confirm people's clinical observation that this happens, and added a few lab measurements to support how it might be happening."

The nonrandomized, non-vehicle-controlled study was funded by Valeant Pharmaceuticals, and Dr. Kang did not disclose any conflicts of interest.

The study included 21 subjects, aged 56–85 years, who received 5% topical 5-FU cream twice daily for 2 weeks for the treatment of facial AK. In addition to AK lesions, all patients had moderate to severe photodamage.

The subjects underwent a baseline clinical skin examination, which was repeated 1 day after the last treatment application and again at 4, 10, and 24 weeks post treatment.

Photographic evaluation was performed, and photoaging parameters were assessed according to a photonumeric scale that included wrinkling, roughness, lentigines, hyperpigmentation, and sallowness. Biopsies were also taken at the same time points.

At the end of the study, the number of AKs was reduced from almost 12 to less than 2 per patient. In addition, photoaging scores dropped from slightly less than 5.5 to about 4.6, he reported.

Biopsies were used to examine the molecular end points of epidermal injury, inflammation, dermal matrix degradation, and collagen, Dr. Kang said.

"Epidermal injury causes an inflammatory reaction in the skin, which triggers collagen repair, and we believe this is the mechanism by which topical 5-FU might improve wrinkles," he explained at the meeting.

Biopsies taken at the end of the study showed a seven-fold increase from baseline in keratin 16, a marker of epidermal injury, and a two-fold increase in inflammatory cytokine expression. Additionally, there was a statistically significant increase in the induction of collagenase (MMP-1) and stromelysin (MMP-3), markers of dermal matrix degradation, he said.

Finally, procollagen protein levels increased significantly from baseline, indicating collagen repair.

"Topical 5-FU induces epidermal wounding by a mechanism similar to microdermabrasion and certain lasers used for the treatment of photoaging. Agents that produce irritation could improve photoaging," Dr. Kang concluded.

MONTREAL — Topical 5-fluorouracil used for the treatment of actinic keratosis can also promote dermal remodeling in photoaged skin, according to a small study.

For years, clinicians and patients have noted that, in addition to treating actinic keratosis (AK), topical 5-fluorouracil (5-FU) treatment can result in skin softening and smoothing, Dr. Sewon Kang of Johns Hopkins University, Baltimore, said at the annual meeting of the Society for Investigative Dermatology.

"We knew this anecdotally, but it had never been documented or studied at a molecular level," he said in an interview. "We did this study to confirm people's clinical observation that this happens, and added a few lab measurements to support how it might be happening."

The nonrandomized, non-vehicle-controlled study was funded by Valeant Pharmaceuticals, and Dr. Kang did not disclose any conflicts of interest.

The study included 21 subjects, aged 56–85 years, who received 5% topical 5-FU cream twice daily for 2 weeks for the treatment of facial AK. In addition to AK lesions, all patients had moderate to severe photodamage.

The subjects underwent a baseline clinical skin examination, which was repeated 1 day after the last treatment application and again at 4, 10, and 24 weeks post treatment.

Photographic evaluation was performed, and photoaging parameters were assessed according to a photonumeric scale that included wrinkling, roughness, lentigines, hyperpigmentation, and sallowness. Biopsies were also taken at the same time points.

At the end of the study, the number of AKs was reduced from almost 12 to less than 2 per patient. In addition, photoaging scores dropped from slightly less than 5.5 to about 4.6, he reported.

Biopsies were used to examine the molecular end points of epidermal injury, inflammation, dermal matrix degradation, and collagen, Dr. Kang said.

"Epidermal injury causes an inflammatory reaction in the skin, which triggers collagen repair, and we believe this is the mechanism by which topical 5-FU might improve wrinkles," he explained at the meeting.

Biopsies taken at the end of the study showed a seven-fold increase from baseline in keratin 16, a marker of epidermal injury, and a two-fold increase in inflammatory cytokine expression. Additionally, there was a statistically significant increase in the induction of collagenase (MMP-1) and stromelysin (MMP-3), markers of dermal matrix degradation, he said.

Finally, procollagen protein levels increased significantly from baseline, indicating collagen repair.

"Topical 5-FU induces epidermal wounding by a mechanism similar to microdermabrasion and certain lasers used for the treatment of photoaging. Agents that produce irritation could improve photoaging," Dr. Kang concluded.

MONTREAL — Topical 5-fluorouracil used for the treatment of actinic keratosis can also promote dermal remodeling in photoaged skin, according to a small study.

For years, clinicians and patients have noted that, in addition to treating actinic keratosis (AK), topical 5-fluorouracil (5-FU) treatment can result in skin softening and smoothing, Dr. Sewon Kang of Johns Hopkins University, Baltimore, said at the annual meeting of the Society for Investigative Dermatology.

"We knew this anecdotally, but it had never been documented or studied at a molecular level," he said in an interview. "We did this study to confirm people's clinical observation that this happens, and added a few lab measurements to support how it might be happening."

The nonrandomized, non-vehicle-controlled study was funded by Valeant Pharmaceuticals, and Dr. Kang did not disclose any conflicts of interest.

The study included 21 subjects, aged 56–85 years, who received 5% topical 5-FU cream twice daily for 2 weeks for the treatment of facial AK. In addition to AK lesions, all patients had moderate to severe photodamage.

The subjects underwent a baseline clinical skin examination, which was repeated 1 day after the last treatment application and again at 4, 10, and 24 weeks post treatment.

Photographic evaluation was performed, and photoaging parameters were assessed according to a photonumeric scale that included wrinkling, roughness, lentigines, hyperpigmentation, and sallowness. Biopsies were also taken at the same time points.

At the end of the study, the number of AKs was reduced from almost 12 to less than 2 per patient. In addition, photoaging scores dropped from slightly less than 5.5 to about 4.6, he reported.

Biopsies were used to examine the molecular end points of epidermal injury, inflammation, dermal matrix degradation, and collagen, Dr. Kang said.

"Epidermal injury causes an inflammatory reaction in the skin, which triggers collagen repair, and we believe this is the mechanism by which topical 5-FU might improve wrinkles," he explained at the meeting.

Biopsies taken at the end of the study showed a seven-fold increase from baseline in keratin 16, a marker of epidermal injury, and a two-fold increase in inflammatory cytokine expression. Additionally, there was a statistically significant increase in the induction of collagenase (MMP-1) and stromelysin (MMP-3), markers of dermal matrix degradation, he said.

Finally, procollagen protein levels increased significantly from baseline, indicating collagen repair.

"Topical 5-FU induces epidermal wounding by a mechanism similar to microdermabrasion and certain lasers used for the treatment of photoaging. Agents that produce irritation could improve photoaging," Dr. Kang concluded.

NATIONAL HARBOR, MD. — Improvement in melasma severity achieved by fractional photothermolysis lasted for a mean 13 months in five of eight patients, while the other three had recurrences in the first-ever study to follow these patients beyond 6 months.

"For refractory melasma, nonablative fractional photothermolysis is a good treatment option with long-term remission," Dr. Tracy M. Katz said at the annual meeting of the American Society for Laser Medicine and Surgery.

The device used in the study was a 1,550-nm erbium-doped Fraxel laser. Treatments were performed at 6–40 mJ (starting low in all patients and increasing in some), with eight passes per treatment at levels of 4–10; this corresponded to surface area coverage of 14%-29%. The laser settings were chosen based on the patients' skin type, with a maximum level of 7 for darker skin and up to 10 for lighter skin, said Dr. Katz of DermSurgery Associates, Houston.

A forced-air cooling device was set at low settings of 2–3 to decrease inflammation and reduce the risk of postinflammatory hyperpigmentation.

The eight women had a mean age of 44 years (range 27–57), with skin types II-IV, and they had melasma on the face that was refractory to hydroquinone and other traditional treatments. The mean duration of disease was 6 years. Each patient underwent two to seven treatments, at intervals of 4–6 weeks for lighter skin and 6–8 weeks for darker skin. Topical triple anesthetic was applied 1 hour prior to treatment.

Patients were instructed to use hydroquinone until 2–3 days prior to each treatment and then to restart it after their skin had healed and continue it for 2–6 months after the last laser treatment. They were seen for follow-up anywhere from 7 to 36 months after their last laser treatment, with a mean follow-up of 13 months.

Assessments were determined via side-by-side photo analysis by the treating physician (Dr. Paul Friedman) and a nontreating physician (Dr. Katz), based on a well-established quartile grading system of 1%-25%, 26%-50%, 51%-75%, and greater than 75%. At the last treatment session, two patients achieved more than 75% improvement, four had 51%-75% improvement, one had 26%-50%, and one had 1%-25% improvement.

During 7–36 months' follow-up, five patients had maintained their initial level of improvement and three had recurrence of their melasma. Two of those three patients had the lowest initial improvement (1%-25% and 26%-50%), Dr. Katz reported. Energy settings correlate with an increased depth of thermal injury, and pigment in dermal melasma is usually found up to the papillary/reticular dermal junction around 500 micrometers, with pigment being rare beyond 700 micrometers. Knowing this, energies up to 30 mJ should target most pigment, she noted.

Dr. Katz stated that there were no financial disclosures associated with her presentation.

NATIONAL HARBOR, MD. — Improvement in melasma severity achieved by fractional photothermolysis lasted for a mean 13 months in five of eight patients, while the other three had recurrences in the first-ever study to follow these patients beyond 6 months.

"For refractory melasma, nonablative fractional photothermolysis is a good treatment option with long-term remission," Dr. Tracy M. Katz said at the annual meeting of the American Society for Laser Medicine and Surgery.

The device used in the study was a 1,550-nm erbium-doped Fraxel laser. Treatments were performed at 6–40 mJ (starting low in all patients and increasing in some), with eight passes per treatment at levels of 4–10; this corresponded to surface area coverage of 14%-29%. The laser settings were chosen based on the patients' skin type, with a maximum level of 7 for darker skin and up to 10 for lighter skin, said Dr. Katz of DermSurgery Associates, Houston.

A forced-air cooling device was set at low settings of 2–3 to decrease inflammation and reduce the risk of postinflammatory hyperpigmentation.

The eight women had a mean age of 44 years (range 27–57), with skin types II-IV, and they had melasma on the face that was refractory to hydroquinone and other traditional treatments. The mean duration of disease was 6 years. Each patient underwent two to seven treatments, at intervals of 4–6 weeks for lighter skin and 6–8 weeks for darker skin. Topical triple anesthetic was applied 1 hour prior to treatment.

Patients were instructed to use hydroquinone until 2–3 days prior to each treatment and then to restart it after their skin had healed and continue it for 2–6 months after the last laser treatment. They were seen for follow-up anywhere from 7 to 36 months after their last laser treatment, with a mean follow-up of 13 months.

Assessments were determined via side-by-side photo analysis by the treating physician (Dr. Paul Friedman) and a nontreating physician (Dr. Katz), based on a well-established quartile grading system of 1%-25%, 26%-50%, 51%-75%, and greater than 75%. At the last treatment session, two patients achieved more than 75% improvement, four had 51%-75% improvement, one had 26%-50%, and one had 1%-25% improvement.

During 7–36 months' follow-up, five patients had maintained their initial level of improvement and three had recurrence of their melasma. Two of those three patients had the lowest initial improvement (1%-25% and 26%-50%), Dr. Katz reported. Energy settings correlate with an increased depth of thermal injury, and pigment in dermal melasma is usually found up to the papillary/reticular dermal junction around 500 micrometers, with pigment being rare beyond 700 micrometers. Knowing this, energies up to 30 mJ should target most pigment, she noted.

Dr. Katz stated that there were no financial disclosures associated with her presentation.

NATIONAL HARBOR, MD. — Improvement in melasma severity achieved by fractional photothermolysis lasted for a mean 13 months in five of eight patients, while the other three had recurrences in the first-ever study to follow these patients beyond 6 months.

"For refractory melasma, nonablative fractional photothermolysis is a good treatment option with long-term remission," Dr. Tracy M. Katz said at the annual meeting of the American Society for Laser Medicine and Surgery.

The device used in the study was a 1,550-nm erbium-doped Fraxel laser. Treatments were performed at 6–40 mJ (starting low in all patients and increasing in some), with eight passes per treatment at levels of 4–10; this corresponded to surface area coverage of 14%-29%. The laser settings were chosen based on the patients' skin type, with a maximum level of 7 for darker skin and up to 10 for lighter skin, said Dr. Katz of DermSurgery Associates, Houston.

A forced-air cooling device was set at low settings of 2–3 to decrease inflammation and reduce the risk of postinflammatory hyperpigmentation.

The eight women had a mean age of 44 years (range 27–57), with skin types II-IV, and they had melasma on the face that was refractory to hydroquinone and other traditional treatments. The mean duration of disease was 6 years. Each patient underwent two to seven treatments, at intervals of 4–6 weeks for lighter skin and 6–8 weeks for darker skin. Topical triple anesthetic was applied 1 hour prior to treatment.

Patients were instructed to use hydroquinone until 2–3 days prior to each treatment and then to restart it after their skin had healed and continue it for 2–6 months after the last laser treatment. They were seen for follow-up anywhere from 7 to 36 months after their last laser treatment, with a mean follow-up of 13 months.

Assessments were determined via side-by-side photo analysis by the treating physician (Dr. Paul Friedman) and a nontreating physician (Dr. Katz), based on a well-established quartile grading system of 1%-25%, 26%-50%, 51%-75%, and greater than 75%. At the last treatment session, two patients achieved more than 75% improvement, four had 51%-75% improvement, one had 26%-50%, and one had 1%-25% improvement.

During 7–36 months' follow-up, five patients had maintained their initial level of improvement and three had recurrence of their melasma. Two of those three patients had the lowest initial improvement (1%-25% and 26%-50%), Dr. Katz reported. Energy settings correlate with an increased depth of thermal injury, and pigment in dermal melasma is usually found up to the papillary/reticular dermal junction around 500 micrometers, with pigment being rare beyond 700 micrometers. Knowing this, energies up to 30 mJ should target most pigment, she noted.

Dr. Katz stated that there were no financial disclosures associated with her presentation.

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

MIAMI BEACH — Remember the three P's of perfect lip enhancement—proportion, profile, and plumping—and you are more likely to get a satisfied patient who will use their new lips to refer other patients to your office.

Always keep proportion in mind—the ideal lip size ratio is about 40% for the top lip to 60% bottom lip, Dr. Glynis R. Ablon said at the South Beach Symposium.

The main goal of augmentation is to give patients natural-looking lips versus an overdone or "trout" lip appearance. "Don't completely change their look," she said, because no one should be able to tell the lips were enhanced.

For guidance, look at very young women or men, depending on what you're doing, "and see what looks natural to you," she said.

Look at each patient in profile and keep in mind you are sculpting the appearance of their lips from all sides, Dr. Ablon said.

Err on the side of injecting less filler material versus too much. "Less is more," Dr. Ablon said.

Start with a small amount and have the patient return for additional enhancement if desired. "Make sure you don't create lips that enter the door before the patient does. Not everyone will look normal with large lips, especially in Hollywood, where I work," commented Dr. Ablon, who is in private practice in Manhattan Beach, Calif., and on the dermatology faculty at the University of California in Los Angeles.

The actress Demi Moore, for example, has thin lips and "might look strange with enhanced lips."

When injecting filler, pay particular attention to the philtrum and cupid's bow on the upper lip, she said. You can also enhance or recreate the Glogau-Klein point, the dimple in the lower lip.

A general rule for the lower lips is to only inject in the central two-thirds. "Don't go too lateral. It will look like sausage otherwise," Dr. Ablon said. One exception, she said, is a patient with significant facial wrinkles who might get improvement to the side of the mouth (below the nasolabial fold).

Always have patients seated upright to allow for normal gravity. Another tip is to start with a nonpermanent filler, something you can dissolve, Dr. Ablon said.

Juvederm (hyaluronic acid, Allergan) is her lip filler product of choice, which she also injects above the vermillion border in some patients to provide additional enhancement. "It is a softer filler, and very moldable and malleable. Patients cannot notice there is anything inside their lips." Collagen and calcium hydroxylapatite are other lip filler choices.

Surgical options include lifts and advanced flaps. "The only surgical approach I typically use is the butterfly lip lift," Dr. Ablon said at the meeting.

The technique is best suited for patients with an elongated philtrum.

The lips are very sensitive and Dr. Ablon recommends use of topical and injected analgesics, such as lidocaine, before augmentation. She also uses the ArTek cooling device (ThermoTek Inc.) to increase patient comfort during the procedure. "If the patient is miserable, they will not return."

Tips to minimize bruising include avoidance of aspirin, nonsteroidal anti-inflammatory drugs, and vitamin E, and addition of bromelain supplements (a compound from pineapple). Also, consider antiviral treatment if the patient has a history of herpes outbreaks.

Dr. Ablon disclosed that she is a member of the Medicis advisory board (makers of Restylane and Perlane fillers).

'Don't create lips that enter the door before the patient does. Not everyone will look normal with large lips.' DR. ABLON

NATIONAL HARBOR, MD. — Nonablative fractional laser resurfacing produced significant improvement in scar severity in a study of 10 patients with second- and third-degree burn scars.

A total of five treatments delivered at 4-week intervals using a 1,550-nm nonablative erbium-doped fiber laser (Fraxel re:store) resulted in objectively-assessed reductions in overall scar severity, as well as improvement in topographical and textural abnormalities, Dr. Jill Waibel reported at the annual meeting of the American Society of Laser Medicine and Surgery.

"Burn scars are a challenge because they have traditionally been difficult to treat, and they are among the worst scars seen in clinical medicine. There is compelling evidence to suggest that nonablative fractional resurfacing improves the appearance and functionality of scarred tissue following burns. I think fractional lasers are the gold standard for scars," said Dr. Waibel, who is in private practice in West Palm Beach, Fla.

Burn scars are extremely heterogeneous, often comprising areas of hypertrophy, atrophy, and hyperpigmentation. Fractional photothermolysis, which provides a greater depth of penetration than traditional CO2 laser resurfacing, appears to benefit the variety of scar types that arise from burn injury, she said.

The eight men and two women in the study ranged in age from 23 to 68 years. Nine had third-degree burns and one had second-degree burns. Treatment areas included the face, neck, chest, arms, hands, abdomen, calf, and leg. Patients were treated with energy levels ranging from 40–70 mJ/pulse, treatment level range 6–13, density 29–65 MTZ/cm

Three blinded investigators evaluated changes in overall improvement, dyschromia, degree of atrophy or hypertrophy improvement, and texture improvement graded on a quartile scale of 0–3, with 0 being none, 1 mild (1%-33%), 2 moderate (34%-66%), and 3 excellent (67%-100%). The patients also scored their own levels of self-esteem, and both the patients and the investigators independently evaluated changes in erythema, edema, hyper- and hypopigmentation, and burn scars overall at 1, 3, and 6 months after the final treatment. Photos were also taken at baseline and at 3 months post treatment.

Based on a protocol recommended by the Food and Drug Administration, the evaluators were given random before and after patient photographs. In one patient, none of the three blinded investigators identified the before and after photos correctly. All three investigators correctly identified the other 9 patient photos, so those 27 evaluations were used for the data analysis.

Overall improvement was noted in all 27 (100%), with 37% scored as excellent, 41% as moderate, and 22% as mild. Improved dyschromia was noted in 96% of the blinded evaluations, with 60% having at least moderately improved. Improvements in atrophy/hypertrophy were also noted in 96%, with 63% having at least moderately improved. Improved skin texture was seen in 100%, with 63% having at least moderately improved texture, Dr. Waibel reported.

The average of the patients' self-assessments of self-esteem at 3 months was 8.2 on a scale of 1–10 with 10 being "I feel great about myself." On a 0–3 scale of improvement in burn scar area with 0 being "no improvement" and 3 being "excellent improvement," the average of the patients' self-assessment at 3 months was 2.3. Anecdotally, patients also spoke of diminished pain, improved motion with a decrease in contractures, and better cosmesis, Dr. Waibel added.

The findings from this study will be submitted to the FDA to support a new indication for burn scars. (Fraxel re:store is currently approved for skin resurfacing.) Additional studies will be necessary to determine the optimal parameters for burn patients, Dr. Waibel said in an interview.

The next phase of studies that Dr. Waibel and her associates are studying include the use of nonablative fractional resurfacing in combination with intralesional triamcinolone (Kenalog), and also the use of ablative fractional resurfacing devices.

Dr. Waibel and her associates received a research grant from Reliant Technologies Inc. (now Solta Medical, Fraxel manufacturer) to conduct this study, and have received honoraria from the company for lectures.

The patient's hand is shown before undergoing treatment with the Fraxel re:store laser.

Three months and five laser treatments later, overall severity of the burn scar is reduced. Photos courtesy Dr. Waibel

NATIONAL HARBOR, MD. — Nonablative fractional laser resurfacing produced significant improvement in scar severity in a study of 10 patients with second- and third-degree burn scars.

A total of five treatments delivered at 4-week intervals using a 1,550-nm nonablative erbium-doped fiber laser (Fraxel re:store) resulted in objectively-assessed reductions in overall scar severity, as well as improvement in topographical and textural abnormalities, Dr. Jill Waibel reported at the annual meeting of the American Society of Laser Medicine and Surgery.

"Burn scars are a challenge because they have traditionally been difficult to treat, and they are among the worst scars seen in clinical medicine. There is compelling evidence to suggest that nonablative fractional resurfacing improves the appearance and functionality of scarred tissue following burns. I think fractional lasers are the gold standard for scars," said Dr. Waibel, who is in private practice in West Palm Beach, Fla.

Burn scars are extremely heterogeneous, often comprising areas of hypertrophy, atrophy, and hyperpigmentation. Fractional photothermolysis, which provides a greater depth of penetration than traditional CO2 laser resurfacing, appears to benefit the variety of scar types that arise from burn injury, she said.

The eight men and two women in the study ranged in age from 23 to 68 years. Nine had third-degree burns and one had second-degree burns. Treatment areas included the face, neck, chest, arms, hands, abdomen, calf, and leg. Patients were treated with energy levels ranging from 40–70 mJ/pulse, treatment level range 6–13, density 29–65 MTZ/cm

Three blinded investigators evaluated changes in overall improvement, dyschromia, degree of atrophy or hypertrophy improvement, and texture improvement graded on a quartile scale of 0–3, with 0 being none, 1 mild (1%-33%), 2 moderate (34%-66%), and 3 excellent (67%-100%). The patients also scored their own levels of self-esteem, and both the patients and the investigators independently evaluated changes in erythema, edema, hyper- and hypopigmentation, and burn scars overall at 1, 3, and 6 months after the final treatment. Photos were also taken at baseline and at 3 months post treatment.

Based on a protocol recommended by the Food and Drug Administration, the evaluators were given random before and after patient photographs. In one patient, none of the three blinded investigators identified the before and after photos correctly. All three investigators correctly identified the other 9 patient photos, so those 27 evaluations were used for the data analysis.

Overall improvement was noted in all 27 (100%), with 37% scored as excellent, 41% as moderate, and 22% as mild. Improved dyschromia was noted in 96% of the blinded evaluations, with 60% having at least moderately improved. Improvements in atrophy/hypertrophy were also noted in 96%, with 63% having at least moderately improved. Improved skin texture was seen in 100%, with 63% having at least moderately improved texture, Dr. Waibel reported.

The average of the patients' self-assessments of self-esteem at 3 months was 8.2 on a scale of 1–10 with 10 being "I feel great about myself." On a 0–3 scale of improvement in burn scar area with 0 being "no improvement" and 3 being "excellent improvement," the average of the patients' self-assessment at 3 months was 2.3. Anecdotally, patients also spoke of diminished pain, improved motion with a decrease in contractures, and better cosmesis, Dr. Waibel added.

The findings from this study will be submitted to the FDA to support a new indication for burn scars. (Fraxel re:store is currently approved for skin resurfacing.) Additional studies will be necessary to determine the optimal parameters for burn patients, Dr. Waibel said in an interview.

The next phase of studies that Dr. Waibel and her associates are studying include the use of nonablative fractional resurfacing in combination with intralesional triamcinolone (Kenalog), and also the use of ablative fractional resurfacing devices.

Dr. Waibel and her associates received a research grant from Reliant Technologies Inc. (now Solta Medical, Fraxel manufacturer) to conduct this study, and have received honoraria from the company for lectures.

The patient's hand is shown before undergoing treatment with the Fraxel re:store laser.

Three months and five laser treatments later, overall severity of the burn scar is reduced. Photos courtesy Dr. Waibel

NATIONAL HARBOR, MD. — Nonablative fractional laser resurfacing produced significant improvement in scar severity in a study of 10 patients with second- and third-degree burn scars.

A total of five treatments delivered at 4-week intervals using a 1,550-nm nonablative erbium-doped fiber laser (Fraxel re:store) resulted in objectively-assessed reductions in overall scar severity, as well as improvement in topographical and textural abnormalities, Dr. Jill Waibel reported at the annual meeting of the American Society of Laser Medicine and Surgery.

"Burn scars are a challenge because they have traditionally been difficult to treat, and they are among the worst scars seen in clinical medicine. There is compelling evidence to suggest that nonablative fractional resurfacing improves the appearance and functionality of scarred tissue following burns. I think fractional lasers are the gold standard for scars," said Dr. Waibel, who is in private practice in West Palm Beach, Fla.

Burn scars are extremely heterogeneous, often comprising areas of hypertrophy, atrophy, and hyperpigmentation. Fractional photothermolysis, which provides a greater depth of penetration than traditional CO2 laser resurfacing, appears to benefit the variety of scar types that arise from burn injury, she said.

The eight men and two women in the study ranged in age from 23 to 68 years. Nine had third-degree burns and one had second-degree burns. Treatment areas included the face, neck, chest, arms, hands, abdomen, calf, and leg. Patients were treated with energy levels ranging from 40–70 mJ/pulse, treatment level range 6–13, density 29–65 MTZ/cm

Three blinded investigators evaluated changes in overall improvement, dyschromia, degree of atrophy or hypertrophy improvement, and texture improvement graded on a quartile scale of 0–3, with 0 being none, 1 mild (1%-33%), 2 moderate (34%-66%), and 3 excellent (67%-100%). The patients also scored their own levels of self-esteem, and both the patients and the investigators independently evaluated changes in erythema, edema, hyper- and hypopigmentation, and burn scars overall at 1, 3, and 6 months after the final treatment. Photos were also taken at baseline and at 3 months post treatment.

Based on a protocol recommended by the Food and Drug Administration, the evaluators were given random before and after patient photographs. In one patient, none of the three blinded investigators identified the before and after photos correctly. All three investigators correctly identified the other 9 patient photos, so those 27 evaluations were used for the data analysis.

Overall improvement was noted in all 27 (100%), with 37% scored as excellent, 41% as moderate, and 22% as mild. Improved dyschromia was noted in 96% of the blinded evaluations, with 60% having at least moderately improved. Improvements in atrophy/hypertrophy were also noted in 96%, with 63% having at least moderately improved. Improved skin texture was seen in 100%, with 63% having at least moderately improved texture, Dr. Waibel reported.

The average of the patients' self-assessments of self-esteem at 3 months was 8.2 on a scale of 1–10 with 10 being "I feel great about myself." On a 0–3 scale of improvement in burn scar area with 0 being "no improvement" and 3 being "excellent improvement," the average of the patients' self-assessment at 3 months was 2.3. Anecdotally, patients also spoke of diminished pain, improved motion with a decrease in contractures, and better cosmesis, Dr. Waibel added.

The findings from this study will be submitted to the FDA to support a new indication for burn scars. (Fraxel re:store is currently approved for skin resurfacing.) Additional studies will be necessary to determine the optimal parameters for burn patients, Dr. Waibel said in an interview.

The next phase of studies that Dr. Waibel and her associates are studying include the use of nonablative fractional resurfacing in combination with intralesional triamcinolone (Kenalog), and also the use of ablative fractional resurfacing devices.

Dr. Waibel and her associates received a research grant from Reliant Technologies Inc. (now Solta Medical, Fraxel manufacturer) to conduct this study, and have received honoraria from the company for lectures.

The patient's hand is shown before undergoing treatment with the Fraxel re:store laser.

Three months and five laser treatments later, overall severity of the burn scar is reduced. Photos courtesy Dr. Waibel

NATIONAL HARBOR, MD. — Fractional laser resurfacing produced long-term results in a small study of patients treated for acne scarring or photodamage.

Fractional deep dermal ablation is a newer modality that produces clinical improvement in photodamaged skin and acne scarring but with reduced downtime and a lower risk of complications, compared with traditional carbon dioxide resurfacing. However, the long-term outcomes of patients treated with fractional resurfacing have not been previously reported, Dr. Arisa Ortiz said at the annual meeting of the American Society for Laser Medicine and Surgery.

In the current study, results at 1–2 years were somewhat diminished, compared with those seen at 3 months, but were still better than at baseline and patient satisfaction was maintained, said Dr. Ortiz of the University of California, Irvine.

The single-center study involved six patients with acne scarring and four with photodamage. All had been previously enrolled in studies of fractional resurfacing for those two conditions. They were aged 24–63 years, with skin types I-V. There were no serious adverse events associated with the treatment, she said.

All 10 patients returned at 3 months for assessments of improvement in skin texture, rhytids, pigmentation, skin laxity, acne scarring, and overall appearance, compared with baseline.

The patients with acne scarring were then reassessed at 1 year and the patients with photodamage, at 2 years. Three investigators clinically rated improvement on a quartile scale: 0% (no improvement), less than 25% (minor), 25%-50% (minor to moderate), 51%-75% (moderate), and greater than 75% (marked).

Among the acne scarring patients, at 1 year there was 83% maintenance of the initial overall improvement seen at 3 months. For those treated for photoaging, 50% of the 3-month improvement was maintained at 2 years. Overall, there was a 74% improvement from 3 months to the 1- or 2-year follow-up assessment. No patient returned to baseline levels, Dr. Ortiz reported.

Possible explanations for the difference in results between 3 months and the long-term visit include relaxation of tightening, progression of normal aging, or persistent inflammatory changes present at 3 months, as evidenced by heat shock protein activity and ongoing collagen remodeling seen in previous histologic studies.

These results suggest that additional treatments may be necessary to enhance long-term results. It also appeared that acne scarring requires more treatments at higher energies, compared with photodamaged skin, and that performing more frequent treatments early on may result in less bleeding and less downtime for all patients, Dr. Ortiz said.

The original study was funded by Reliant Technologies Inc., but this long-term follow-up study was departmentally funded, she said.

As demonstrated above, results at 1 year (far right) were somewhat diminished—compared with those seen at 3 months (center)—but were still better than at baseline (left), and patient satisfaction was maintained, according to Dr. Arisa Ortiz. Photos courtesy Dr. Arisa Ortiz

NATIONAL HARBOR, MD. — Fractional laser resurfacing produced long-term results in a small study of patients treated for acne scarring or photodamage.

Fractional deep dermal ablation is a newer modality that produces clinical improvement in photodamaged skin and acne scarring but with reduced downtime and a lower risk of complications, compared with traditional carbon dioxide resurfacing. However, the long-term outcomes of patients treated with fractional resurfacing have not been previously reported, Dr. Arisa Ortiz said at the annual meeting of the American Society for Laser Medicine and Surgery.

In the current study, results at 1–2 years were somewhat diminished, compared with those seen at 3 months, but were still better than at baseline and patient satisfaction was maintained, said Dr. Ortiz of the University of California, Irvine.

The single-center study involved six patients with acne scarring and four with photodamage. All had been previously enrolled in studies of fractional resurfacing for those two conditions. They were aged 24–63 years, with skin types I-V. There were no serious adverse events associated with the treatment, she said.

All 10 patients returned at 3 months for assessments of improvement in skin texture, rhytids, pigmentation, skin laxity, acne scarring, and overall appearance, compared with baseline.

The patients with acne scarring were then reassessed at 1 year and the patients with photodamage, at 2 years. Three investigators clinically rated improvement on a quartile scale: 0% (no improvement), less than 25% (minor), 25%-50% (minor to moderate), 51%-75% (moderate), and greater than 75% (marked).

Among the acne scarring patients, at 1 year there was 83% maintenance of the initial overall improvement seen at 3 months. For those treated for photoaging, 50% of the 3-month improvement was maintained at 2 years. Overall, there was a 74% improvement from 3 months to the 1- or 2-year follow-up assessment. No patient returned to baseline levels, Dr. Ortiz reported.

Possible explanations for the difference in results between 3 months and the long-term visit include relaxation of tightening, progression of normal aging, or persistent inflammatory changes present at 3 months, as evidenced by heat shock protein activity and ongoing collagen remodeling seen in previous histologic studies.

These results suggest that additional treatments may be necessary to enhance long-term results. It also appeared that acne scarring requires more treatments at higher energies, compared with photodamaged skin, and that performing more frequent treatments early on may result in less bleeding and less downtime for all patients, Dr. Ortiz said.

The original study was funded by Reliant Technologies Inc., but this long-term follow-up study was departmentally funded, she said.

As demonstrated above, results at 1 year (far right) were somewhat diminished—compared with those seen at 3 months (center)—but were still better than at baseline (left), and patient satisfaction was maintained, according to Dr. Arisa Ortiz. Photos courtesy Dr. Arisa Ortiz

NATIONAL HARBOR, MD. — Fractional laser resurfacing produced long-term results in a small study of patients treated for acne scarring or photodamage.

Fractional deep dermal ablation is a newer modality that produces clinical improvement in photodamaged skin and acne scarring but with reduced downtime and a lower risk of complications, compared with traditional carbon dioxide resurfacing. However, the long-term outcomes of patients treated with fractional resurfacing have not been previously reported, Dr. Arisa Ortiz said at the annual meeting of the American Society for Laser Medicine and Surgery.

In the current study, results at 1–2 years were somewhat diminished, compared with those seen at 3 months, but were still better than at baseline and patient satisfaction was maintained, said Dr. Ortiz of the University of California, Irvine.

The single-center study involved six patients with acne scarring and four with photodamage. All had been previously enrolled in studies of fractional resurfacing for those two conditions. They were aged 24–63 years, with skin types I-V. There were no serious adverse events associated with the treatment, she said.

All 10 patients returned at 3 months for assessments of improvement in skin texture, rhytids, pigmentation, skin laxity, acne scarring, and overall appearance, compared with baseline.

The patients with acne scarring were then reassessed at 1 year and the patients with photodamage, at 2 years. Three investigators clinically rated improvement on a quartile scale: 0% (no improvement), less than 25% (minor), 25%-50% (minor to moderate), 51%-75% (moderate), and greater than 75% (marked).

Among the acne scarring patients, at 1 year there was 83% maintenance of the initial overall improvement seen at 3 months. For those treated for photoaging, 50% of the 3-month improvement was maintained at 2 years. Overall, there was a 74% improvement from 3 months to the 1- or 2-year follow-up assessment. No patient returned to baseline levels, Dr. Ortiz reported.

Possible explanations for the difference in results between 3 months and the long-term visit include relaxation of tightening, progression of normal aging, or persistent inflammatory changes present at 3 months, as evidenced by heat shock protein activity and ongoing collagen remodeling seen in previous histologic studies.

These results suggest that additional treatments may be necessary to enhance long-term results. It also appeared that acne scarring requires more treatments at higher energies, compared with photodamaged skin, and that performing more frequent treatments early on may result in less bleeding and less downtime for all patients, Dr. Ortiz said.

The original study was funded by Reliant Technologies Inc., but this long-term follow-up study was departmentally funded, she said.

As demonstrated above, results at 1 year (far right) were somewhat diminished—compared with those seen at 3 months (center)—but were still better than at baseline (left), and patient satisfaction was maintained, according to Dr. Arisa Ortiz. Photos courtesy Dr. Arisa Ortiz

NATIONAL HARBOR, MD. — A long-pulsed 595-nm pulsed dye laser rapidly improved ecchymosis resulting from either cosmetic procedures or traumatic injury in a study of 10 patients.

Postprocedural and traumatic ecchymosis is an extremely common problem, particularly with the recent explosive growth in minimally invasive procedures that potentially induce bruising, Dr. Julie K. Karen noted at the annual meeting of the American Society for Laser Medicine and Surgery.

Patients are often motivated to minimize or camouflage bruising to conceal the fact that they have had cosmetic intervention. Current strategies to minimize the bruising, such as discontinuation of nonessential blood thinners; meticulous intraoperative technique; and topical or oral agents such as arnica, vitamin K, and hirudin are not always effective, she said.

"Long-pulsed [pulsed dye laser] may alleviate this common stigma associated with cosmetic intervention by expediting healing," said Dr. Karen of the Laser & Skin Surgery Center of New York, N.Y.

The 10 adult patients had skin types I-IV, with one or more ecchymoses. Each subject served as his or her own control.

One ecchymosis was treated in those who had two, while those with just one ecchymosis had half of the lesion treated. None of the patients had active infections, photosensitivity/photoallergy, pregnancy/lactation, prior irradiation to the ecchymosis site, use of oral retinoids or photosensitizing drugs in the previous 2 years, or a history of keloid formation.

Each patient received a single treatment with a long-pulsed 595-nm pulsed-dye laser (Vbeam, Candela) with these parameters: spot size, 10 mm; fluence, 7.5 J/cm

Treated lesions resolved more rapidly than untreated lesions in all 10 patients. All 10 treated lesions showed improvement within 24 hours, with some improvement evident as early as 6 hours post treatment.

At 24 hours post treatment, there was an average 62% improvement from baseline in the treated lesion compared with just 13% of the untreated lesion. At 48 hours, the improvements were 76% and 37%, respectively. At 1 week post treatment, there was no longer a significant difference between the treated and untreated areas, with both lesions largely resolved (87% vs. 81%).

Side effects were minimal, including slight discomfort, erythema, and edema. Transient crusting occurred in the first two patients, in whom pulse-stacking was attempted. That was avoided in the subsequent eight patients and none had crusting, Dr. Karen said.

The precise mechanism by which laser treatment accelerates the resolution of ecchymosis is unknown. Ecchymoses result when extravasated blood accumulates in tissue. The yellow color that develops in older bruises correlates with macrophage degradation of hemoglobin to bilirubin.

The pulsed dye laser emits yellow light (595-nm) matching an absorption peak of oxyhemoglobin. Since bilirubin has a broad absorption peak of 460-nm, "we posit that laser intervention is most effective if initiated early, when hemoglobin predominates," she commented.

Dr. Karen stated that she had no relevant disclosures.

NATIONAL HARBOR, MD. — A long-pulsed 595-nm pulsed dye laser rapidly improved ecchymosis resulting from either cosmetic procedures or traumatic injury in a study of 10 patients.

Postprocedural and traumatic ecchymosis is an extremely common problem, particularly with the recent explosive growth in minimally invasive procedures that potentially induce bruising, Dr. Julie K. Karen noted at the annual meeting of the American Society for Laser Medicine and Surgery.

Patients are often motivated to minimize or camouflage bruising to conceal the fact that they have had cosmetic intervention. Current strategies to minimize the bruising, such as discontinuation of nonessential blood thinners; meticulous intraoperative technique; and topical or oral agents such as arnica, vitamin K, and hirudin are not always effective, she said.

"Long-pulsed [pulsed dye laser] may alleviate this common stigma associated with cosmetic intervention by expediting healing," said Dr. Karen of the Laser & Skin Surgery Center of New York, N.Y.

The 10 adult patients had skin types I-IV, with one or more ecchymoses. Each subject served as his or her own control.

One ecchymosis was treated in those who had two, while those with just one ecchymosis had half of the lesion treated. None of the patients had active infections, photosensitivity/photoallergy, pregnancy/lactation, prior irradiation to the ecchymosis site, use of oral retinoids or photosensitizing drugs in the previous 2 years, or a history of keloid formation.

Each patient received a single treatment with a long-pulsed 595-nm pulsed-dye laser (Vbeam, Candela) with these parameters: spot size, 10 mm; fluence, 7.5 J/cm

Treated lesions resolved more rapidly than untreated lesions in all 10 patients. All 10 treated lesions showed improvement within 24 hours, with some improvement evident as early as 6 hours post treatment.

At 24 hours post treatment, there was an average 62% improvement from baseline in the treated lesion compared with just 13% of the untreated lesion. At 48 hours, the improvements were 76% and 37%, respectively. At 1 week post treatment, there was no longer a significant difference between the treated and untreated areas, with both lesions largely resolved (87% vs. 81%).

Side effects were minimal, including slight discomfort, erythema, and edema. Transient crusting occurred in the first two patients, in whom pulse-stacking was attempted. That was avoided in the subsequent eight patients and none had crusting, Dr. Karen said.

The precise mechanism by which laser treatment accelerates the resolution of ecchymosis is unknown. Ecchymoses result when extravasated blood accumulates in tissue. The yellow color that develops in older bruises correlates with macrophage degradation of hemoglobin to bilirubin.

The pulsed dye laser emits yellow light (595-nm) matching an absorption peak of oxyhemoglobin. Since bilirubin has a broad absorption peak of 460-nm, "we posit that laser intervention is most effective if initiated early, when hemoglobin predominates," she commented.

Dr. Karen stated that she had no relevant disclosures.

NATIONAL HARBOR, MD. — A long-pulsed 595-nm pulsed dye laser rapidly improved ecchymosis resulting from either cosmetic procedures or traumatic injury in a study of 10 patients.

Postprocedural and traumatic ecchymosis is an extremely common problem, particularly with the recent explosive growth in minimally invasive procedures that potentially induce bruising, Dr. Julie K. Karen noted at the annual meeting of the American Society for Laser Medicine and Surgery.

Patients are often motivated to minimize or camouflage bruising to conceal the fact that they have had cosmetic intervention. Current strategies to minimize the bruising, such as discontinuation of nonessential blood thinners; meticulous intraoperative technique; and topical or oral agents such as arnica, vitamin K, and hirudin are not always effective, she said.

"Long-pulsed [pulsed dye laser] may alleviate this common stigma associated with cosmetic intervention by expediting healing," said Dr. Karen of the Laser & Skin Surgery Center of New York, N.Y.

The 10 adult patients had skin types I-IV, with one or more ecchymoses. Each subject served as his or her own control.

One ecchymosis was treated in those who had two, while those with just one ecchymosis had half of the lesion treated. None of the patients had active infections, photosensitivity/photoallergy, pregnancy/lactation, prior irradiation to the ecchymosis site, use of oral retinoids or photosensitizing drugs in the previous 2 years, or a history of keloid formation.

Each patient received a single treatment with a long-pulsed 595-nm pulsed-dye laser (Vbeam, Candela) with these parameters: spot size, 10 mm; fluence, 7.5 J/cm

Treated lesions resolved more rapidly than untreated lesions in all 10 patients. All 10 treated lesions showed improvement within 24 hours, with some improvement evident as early as 6 hours post treatment.

At 24 hours post treatment, there was an average 62% improvement from baseline in the treated lesion compared with just 13% of the untreated lesion. At 48 hours, the improvements were 76% and 37%, respectively. At 1 week post treatment, there was no longer a significant difference between the treated and untreated areas, with both lesions largely resolved (87% vs. 81%).

Side effects were minimal, including slight discomfort, erythema, and edema. Transient crusting occurred in the first two patients, in whom pulse-stacking was attempted. That was avoided in the subsequent eight patients and none had crusting, Dr. Karen said.

The precise mechanism by which laser treatment accelerates the resolution of ecchymosis is unknown. Ecchymoses result when extravasated blood accumulates in tissue. The yellow color that develops in older bruises correlates with macrophage degradation of hemoglobin to bilirubin.

The pulsed dye laser emits yellow light (595-nm) matching an absorption peak of oxyhemoglobin. Since bilirubin has a broad absorption peak of 460-nm, "we posit that laser intervention is most effective if initiated early, when hemoglobin predominates," she commented.

Dr. Karen stated that she had no relevant disclosures.

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SAN FRANCISCO — Growth hormone therapy might help adults with a deficiency, but there's no evidence that it helps normal elderly adults or athletes.

Illegal use in antiaging clinics probably accounts for the largest use of growth hormone in the United States today, Dr. Andrew R. Hoffman said.

The therapy is indicated for adults for the treatment of growth hormone deficiency caused by pituitary disease, hypothalamic disease, surgery, radiation, or trauma. It is the only drug in the U.S. that cannot legally be prescribed off label, he said at a meeting on diabetes and endocrinology sponsored by the University of California, San Francisco.

What's more, its use in normal elderly people may cause harm by inducing glucose intolerance or increasing the risk for cancer, “although we do not know that” for sure, said Dr. Hoffman, professor of medicine at Stanford (Calif.) University and the Veterans Affairs Palo Alto Health Care System.

Interest in treating normal age-related declines in growth hormone secretion and insulin-like growth factor 1 (IGF-1)—dubbed the “somatopause”—zoomed after a 1999 study reported that giving growth hormone injections to male veterans aged older than 60 years for 6 months increased lean tissue mass by 9%, skin thickness by 7%, and lower-back vertebral density by 2%, while decreasing fatty tissue by 14% (N. Engl. J. Med. 1990;323:1-6). The authors described the effects as equivalent in magnitude to the changes that occur during 10-20 years of aging. “This set up a lot of excitement and was the basis for all the antiaging clinics you can find,” Dr. Hoffman said.

It also generated multiple animal studies by the National Institutes of Health, every one of which showed that longevity is associated with lower growth hormone levels, not higher ones. A systematic review of randomized, controlled trials of growth hormone injections in healthy elderly humans reported small changes in body composition and high rates of adverse events (Ann. Intern. Med. 2007;146:104-15).

One of the potential side effects with growth hormone overtreatment is increased edema. “You can't say it increases muscle,” Dr. Hoffman said. “Much of it might be fluid retention.”

The medical literature suggests that treatment probably is helpful for patients with growth hormone deficiency syndrome, Dr. Hoffman said. Treatment produces significant and durable changes in cardiac effects. Bodily fat mass, LDL cholesterol, and total cholesterol levels decrease but insulin and glucose levels tend to increase.

In general, patients treated for growth hormone deficiency syndrome become more physically active, increase their strength and exercise capacity, and slightly increase bone mineral density.

Other data suggest, however, that high levels of IGF-1 over long periods of time could increase the risk for prostate cancer or premenopausal breast cancer.

Dr. Hoffman has received research support, owned stock, or been a consultant to companies that market growth hormone or related products, including Ambryx, LG Life Science, Tercica, Merck Serono, Pfizer, Novo Nordisk, and Teva Pharmaceutical Industries.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

SCOTTSDALE, ARIZ. — Silicone or saline?

With 550,000 breast augmentations performed each year in the United States, it's a question physicians and surgeons get asked a lot.

Today, most women choose silicone. Indeed, silicone gel breast implants have dominated the marketplace since November 2006, when the Food and Drug Administration lifted its moratorium on their primary cosmetic use. Silicone gel now accounts for 56% of all breast implants; saline implants, for 44%. But many women who opt for silicone gel implants don't fully appreciate the higher long-term complication rate, one expert said at the annual meeting of the American Academy of Cosmetic Surgery.

"It's really important for these young ladies to understand what they're getting in for 10-20 years from now, because often the complications are not reversible," explained Dr. Erik J. Nuveen, an Oklahoma City cosmetic surgeon who has performed more than 4,000 breast augmentations.

Dr. Nuveen uses both silicone and saline implants. In presurgical counseling, he has witnessed how the tactile experience of handling the silicone devices in the consultation room can influence the selection. This makes it all the more critical, he stressed, that a woman fully understands the pros and cons of both implant types before making her decision.

"The silicone gel implants are softer, more natural feeling. It's alluring to place one on the table and then put it in the patient's hand. You put a saline [implant] in the other hand and, sure enough, 99% of patients say, 'I've got to get that silicone gel,'" he said.

Silicone breast implants' purported association with connective tissue diseases—the debunked controversy that prompted the former FDA moratorium—has distracted attention from other, very real problems with silicone gel implants, he said.

An estimated 45% of women receiving silicone implants undergo reoperations within 10 years. In practical terms, this means that among women receiving silicone gel breast implants this year, there will be 138,600 reoperations for device rupture, contracture, pain, or loss of shape within the coming decade.

In contrast, the 10-year reoperation rate with saline implants is 20%-26%—roughly half the rate for silicone gel implants.

"These numbers are really important to me. They directly impact how I advise patients in order to minimize complications in their lives at 10 years," Dr. Nuveen continued.

Extracapsular rupture of a silicone gel implant with resultant migration of a silicone stream is a major problem. The silicone must be surgically removed before it can reach the lungs or other vital organs—and that involves a lumpectomy or mastectomy.

The extracapsular rupture rate is 1% at the time of implantation, 7% at 5 years, and estimated at 10% at 10 years.

In contrast, rupture of a saline implant is less problematic. Implant deflation is immediately apparent, and the saline is readily absorbed by surrounding tissue. There is no need to remove substantial breast tissue. The rupture rate with saline implants is 3%-10% at 10 years, depending largely on surgeon expertise.

The reoperation rate for capsular contraction is substantially lower with saline implants than silicone gel.

Silicone gel implants require a larger placement incision—a minimum of 5 cm—because they go in full. The implants themselves are more expensive than saline ones. Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter. It's not covered by insurance.

MRI has an 89% sensitivity for detection of implant rupture. In contrast, physical examination of the breast has only 10%-30% sensitivity. Mammography is quite poor at detecting silicone implant rupture while it's still intracapsular and therefore far more easily treated. Moreover, mammography is the No. 1 cause of implant shell failure.

These days the clinical situation in which Dr. Nuveen said he is most comfortable in recommending silicone gel is in the thinnest patients, who are more likely to find saline implants uncomfortable.

Dr. Nuveen said the future of breast augmentation may be a highly cohesive silicone gel known as style 410. It is the most widely used type of implant in Europe but remains investigational in the United States, where large clinical trials are underway. The 3-year U.S. data are encouraging, but longer follow-up is required.

Dr. Nuveen reported having no conflicts of interest.

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

MIAMI BEACH — Dosing, speed of onset, and extent of spread are among differences to anticipate with a second botulinum toxin expected to reach the U.S. market soon, according to physicians who evaluated its safety and efficacy in preclinical trials.

The Food and Drug Administration is reviewing data for Reloxin (botulinum toxin, Ipsen). "This is really exciting—the first new toxin in the market since Botox," Dr. Mark Nestor said at the South Beach Symposium. "We are hoping it will be approved in the next few months."

"The starting out point for us, especially if it comes in a 300-unit vial, is to do the same thing you do now with Botox," said Dr. Nestor, a dermatologist in private practice in Aventura, Fla., and clinical associate professor of dermatology and cutaneous surgery at the University of Miami. "Start out conservatively, and you will finesse this over time." Dr. Nestor is a speaker and consultant for and has received research grants from Medicis. He is also an advisory board member and speaker for Allergan.

There are four important studies that demonstrate its safety and efficacy, said Dr. Joel L. Cohen, principal investigator of one and assistant clinical professor of dermatology at the University of Colorado, Denver. Two studies assessed patient response to a single 50-U treatment and two others to repeat injections over time. Dr. Cohen is a consultant for Medicis and Allergan.

Median time to onset of effect was 2 days in a study of 300 patients who received Reloxin or placebo to treat the glabellar area. At 3 days, about half of patients felt an effect, and by 7 days, cumulative response was 90%, according to patient diaries. Investigators reported median response duration of 117 days. Nine patients had eye problems, including ptosis. A total of five patients experienced serious adverse events, but none were considered related to treatment, said Dr. Cohen, who is also in private practice in Englewood, Colo. Incidence of headache and injection site bleeding were similar to placebo.

A 90% response was also reported in another single treatment trial with 158 patients receiving either the toxin or placebo. There were some slight differences in efficacy compared to the other single treatment trial. Patient diaries indicated median time to effect of 3 days. Researchers found an 85-day median duration of effect. Reloxin also was well tolerated in this study, Dr. Cohen said.

Up to five repeat treatment sessions were allowed in an open-label, multicenter study. Researchers found a greater proportion of responders at each follow-up evaluation. They reported an overall 93% response and 73% of participants had at least a two-grade improvement. Patients older than 65 years were less likely to respond to Reloxin, as were those with severe ratings at baseline. In addition, the toxin appeared to work better in women, compared with men. Repeat injections were well tolerated, Dr. Cohen said.

The majority of treatment-emergent adverse events were mild. Injection site events, ocular events, and headaches were the most common. There were 72 severe adverse events during the study, including 1 death by gunshot, all unrelated to treatment.

Dr. Cohen and his colleagues also conducted a repeat injection study that found no difference between toxin and placebo patients in terms of vital signs or serum assays (no patient developed antibodies). This study included 768 patients allowed up to eight repeat treatments over 2 years. The multiple cycles were well-tolerated and effective, he said. Injection site pain and nasopharyngitis were the most common adverse events. A total of 37 participants had at least one treatment-emergent adverse event, 2% of which were severe.

The injection technique and pattern will be similar because the mechanism of action is the same for Reloxin and Botox (Allergan), Dr. Michael A.C. Kane said. He has served as an adviser and consultant to Medicis and Allergan.

"The dose-response curves are not parallel, so there is no simple conversion between Reloxin and Botox. "It cannot be a simple number multiplier, period," according to Dr. Kane, attending plastic surgeon at the Manhattan Eye, Ear and Throat Hospital in New York City.

Patients who have had both Botox and Reloxin say Botox is a gradual change over days, Dr. Kane said. "The biggest difference [with Reloxin is] patients say it's almost like a sledgehammer hits them—a much more abrupt feeling—they really feel it kick in."

"Migration is probably the biggest issue we will hear," Dr. Kane said. Tissue migration may be related to complex size, and Botox is a larger 900 kd, compared with 500-600 kd for Reloxin. "We know bigger things move more slowly in muscle. But they would have you believe the smaller molecules of Reloxin will spread all over the place."

To put the differences in perspective, Dr. Kane said, "The hyaluronic acid fillers will vary by a greater degree than the differences between the different toxins."

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR

LAS VEGAS — The way Dr. Vic A. Narurkar sees it, multimodal therapy is integral to most noninvasive dermatologic treatments.

"We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined," he said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery. "They complement each other, but we need to do controlled studies to see if there is true synergy, for example, between injectables and fractional resurfacing."

He discussed the role of multimodal therapy for treating several conditions:

▸ Acne and acne scarring. Prevention options include topical and systemic agents and devices for acute treatment. "We then can correct acne scars with Fraxel laser and injectable fillers such as Juvéderm," said Dr. Narurkar, a dermatologist who practices in San Francisco. Posttreatment acne still needs to be controlled with topical agents.

Isolaz, a device from Aesthera Corp., uses pneumatics to cleanse pores mechanically; it is cleared by the Food and Drug Administration to treat pustular and comedonal acne as well as mild to moderate acne vulgaris. "I call this dermatologic fantasy, because it's this extrusion of pores that we all strive for," said Dr. Narurkar, who is also associate professor of clinical dermatology at the University of California, Davis.

"You get mechanical cleansing by the application of gentle suction. What's interesting about this technology is that you can see immediate impact, similar to cortisone injections. If you combine it with topical retinoids and topical antibiotics, you get an even better result."

▸ Rosacea. Prevention and management options include topical agents such as azelaic acid, metronidazole or sulfur, and oral antibiotics. Treatment of diffuse and isolated telangiectasias "is most effective with the use of vascular lasers—pulsed dye or pulsed KTP [potassium-titanyl-phosphate]—or with the second- and third-generation intense pulsed light sources," he said.

▸ Melasma. Dr. Narurkar called this condition "the sin of dermatology," noting that melasma is difficult to treat and manage. "We pretreat with hydroquinones or retinoids," he said. "The only laser I'll use for therapy-resistant melasma is nonablative fractional resurfacing with the Fraxel Re:Store Laser. I haven't had success with any other laser and you can still get recurrence if it is not managed topically."

For posttreatment, he suggests hydroquinones and retinoids and daily use of a broad spectrum sunscreen. "If patients can avoid birth control pills and other estrogen agents, that's even better," he said.

▸ Skin rejuvenation. For optimal results he recommends "the four Rs": retain and replenish with skin care and sunscreen, resurface with devices, relax with botulinum toxins, and refill with dermal fillers.

Acute treatment of mild to moderate photoaging can be achieved via photofacials with pulsed light sources, vascular and pigmented lesion lasers, and mild nonablative fractional resurfacing.

Treatment of moderate to severe photoaging can be achieved with photodynamic therapy and aggressive nonablative and ablative fractional resurfacing. "For advanced photoaging, you can enhance IPL [intense-pulsed light] and PDL [pulsed dye laser] treatments with Levulan," he said. "You need fewer treatments, there are more immediate results, but there is significantly more down time."

Dr. Narurkar disclosed that he is a consultant to and has performed clinical trials for Aesthera Corp., Allergan Inc., BioForm Medical Inc., Palomar Medical Technologies Inc., and Reliant Technologies Inc.

'We can't think of lasers, devices, toxins, fillers, and skin care in isolation; they have to be combined.' DR. NARURKAR