Aesthetic Dermatology

PHOENIX — A 10-patient experiment comparing Juvéderm with Restylane revealed little difference between the two hyaluronic acid fillers, Dr. Seth L. Matarasso reported at a clinical dermatology conference sponsored by Medicis.

Half of each patient's face was injected with Restylane, the other half with Juvéderm. The only difference observed was "perhaps" a little less edema in the lip area with Juvéderm. Cost, flow, redness, and bruising were otherwise comparable, said Dr. Matarasso, professor of dermatology at the University of California, San Francisco.

"As far as discomfort and appearance, I didn't find it that much different," he said.

Two patients returned for botulinum toxin treatments after 6–7 months, he added. The durability of the two fillers appeared comparable at that point, he said.

The U.S. Food and Drug Administration approved Juvéderm, a hyaluronic acid gel marketed by Allergan Inc. for "injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds)."

The approval was based on a 6-month, double-blind, randomized controlled clinical trial in which Juvéderm compared favorably to Zyplast, a bovine-based collagen. Juvéderm provided longer wrinkle correction in that trial, but Dr. Mattarasso said that studies comparing it to other hyaluronic acids are needed. "My suspicion is the complication rate will be [the] same as other hyaluronic acids. I don't know what the advantages will be. … I think it is way too early to tell," he said.

He did not recommend switching from Restylane, which is marketed by Medicis, to Juvéderm, based on the results of his small study. Juvéderm may cause slightly less swelling, but Dr. Matarasso said that the limited evidence was not a reason to change products. "I think you should pick a product you feel comfortable with, and then branch out," he said.

The ideal filler does not exist, according to Dr. Matarasso, but new products are giving cosmetic dermatologists "an incredible buffet" from which to choose. The deciding factors ultimately will be how the product feels in the clinician's hands and how much the patient likes it, he predicted.

Theoretically, hyaluronic acid fillers are nonallergenic, but Dr. Matarasso said they can cause hypersensitivity reactions. Juvéderm is contraindicated in patients with severe allergies and/or a history of allergies to gram-positive bacterial proteins.

Hyaluronic acid fillers do not include anesthesia and can cause discomfort, so a topical anesthetic—he uses EMLA cream or Betacaine—should be applied before procedures. "Patients don't want a nerve block," he said, and added that patients should be told to expect some edema.

Another new hyaluronic acid filler, Perlane, was approved by the FDA in May ("New Hyaluronic Acid Gel Filler Receives Approval," SKIN & ALLERGY NEWS, June 2007, p. 9).

Clinicians should be aware of products available abroad because patients are returning from overseas trips with complications from injections of fillers not approved by the FDA. "I see a lot of people from the Pacific rim and Australia," he said. "What is astonishing to me is they have injectables, and they don't know what was injected into their face."

Dr. Matarasso has served as a consultant to Allergan and Medicis.

Juvéderm may cause slightlyless swelling, but there's not enough evidence to change products. DR. MATARASSO

PHOENIX — A 10-patient experiment comparing Juvéderm with Restylane revealed little difference between the two hyaluronic acid fillers, Dr. Seth L. Matarasso reported at a clinical dermatology conference sponsored by Medicis.

Half of each patient's face was injected with Restylane, the other half with Juvéderm. The only difference observed was "perhaps" a little less edema in the lip area with Juvéderm. Cost, flow, redness, and bruising were otherwise comparable, said Dr. Matarasso, professor of dermatology at the University of California, San Francisco.

"As far as discomfort and appearance, I didn't find it that much different," he said.

Two patients returned for botulinum toxin treatments after 6–7 months, he added. The durability of the two fillers appeared comparable at that point, he said.

The U.S. Food and Drug Administration approved Juvéderm, a hyaluronic acid gel marketed by Allergan Inc. for "injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds)."

The approval was based on a 6-month, double-blind, randomized controlled clinical trial in which Juvéderm compared favorably to Zyplast, a bovine-based collagen. Juvéderm provided longer wrinkle correction in that trial, but Dr. Mattarasso said that studies comparing it to other hyaluronic acids are needed. "My suspicion is the complication rate will be [the] same as other hyaluronic acids. I don't know what the advantages will be. … I think it is way too early to tell," he said.

He did not recommend switching from Restylane, which is marketed by Medicis, to Juvéderm, based on the results of his small study. Juvéderm may cause slightly less swelling, but Dr. Matarasso said that the limited evidence was not a reason to change products. "I think you should pick a product you feel comfortable with, and then branch out," he said.

The ideal filler does not exist, according to Dr. Matarasso, but new products are giving cosmetic dermatologists "an incredible buffet" from which to choose. The deciding factors ultimately will be how the product feels in the clinician's hands and how much the patient likes it, he predicted.

Theoretically, hyaluronic acid fillers are nonallergenic, but Dr. Matarasso said they can cause hypersensitivity reactions. Juvéderm is contraindicated in patients with severe allergies and/or a history of allergies to gram-positive bacterial proteins.

Hyaluronic acid fillers do not include anesthesia and can cause discomfort, so a topical anesthetic—he uses EMLA cream or Betacaine—should be applied before procedures. "Patients don't want a nerve block," he said, and added that patients should be told to expect some edema.

Another new hyaluronic acid filler, Perlane, was approved by the FDA in May ("New Hyaluronic Acid Gel Filler Receives Approval," SKIN & ALLERGY NEWS, June 2007, p. 9).

Clinicians should be aware of products available abroad because patients are returning from overseas trips with complications from injections of fillers not approved by the FDA. "I see a lot of people from the Pacific rim and Australia," he said. "What is astonishing to me is they have injectables, and they don't know what was injected into their face."

Dr. Matarasso has served as a consultant to Allergan and Medicis.

Juvéderm may cause slightlyless swelling, but there's not enough evidence to change products. DR. MATARASSO

PHOENIX — A 10-patient experiment comparing Juvéderm with Restylane revealed little difference between the two hyaluronic acid fillers, Dr. Seth L. Matarasso reported at a clinical dermatology conference sponsored by Medicis.

Half of each patient's face was injected with Restylane, the other half with Juvéderm. The only difference observed was "perhaps" a little less edema in the lip area with Juvéderm. Cost, flow, redness, and bruising were otherwise comparable, said Dr. Matarasso, professor of dermatology at the University of California, San Francisco.

"As far as discomfort and appearance, I didn't find it that much different," he said.

Two patients returned for botulinum toxin treatments after 6–7 months, he added. The durability of the two fillers appeared comparable at that point, he said.

The U.S. Food and Drug Administration approved Juvéderm, a hyaluronic acid gel marketed by Allergan Inc. for "injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds)."

The approval was based on a 6-month, double-blind, randomized controlled clinical trial in which Juvéderm compared favorably to Zyplast, a bovine-based collagen. Juvéderm provided longer wrinkle correction in that trial, but Dr. Mattarasso said that studies comparing it to other hyaluronic acids are needed. "My suspicion is the complication rate will be [the] same as other hyaluronic acids. I don't know what the advantages will be. … I think it is way too early to tell," he said.

He did not recommend switching from Restylane, which is marketed by Medicis, to Juvéderm, based on the results of his small study. Juvéderm may cause slightly less swelling, but Dr. Matarasso said that the limited evidence was not a reason to change products. "I think you should pick a product you feel comfortable with, and then branch out," he said.

The ideal filler does not exist, according to Dr. Matarasso, but new products are giving cosmetic dermatologists "an incredible buffet" from which to choose. The deciding factors ultimately will be how the product feels in the clinician's hands and how much the patient likes it, he predicted.

Theoretically, hyaluronic acid fillers are nonallergenic, but Dr. Matarasso said they can cause hypersensitivity reactions. Juvéderm is contraindicated in patients with severe allergies and/or a history of allergies to gram-positive bacterial proteins.

Hyaluronic acid fillers do not include anesthesia and can cause discomfort, so a topical anesthetic—he uses EMLA cream or Betacaine—should be applied before procedures. "Patients don't want a nerve block," he said, and added that patients should be told to expect some edema.

Another new hyaluronic acid filler, Perlane, was approved by the FDA in May ("New Hyaluronic Acid Gel Filler Receives Approval," SKIN & ALLERGY NEWS, June 2007, p. 9).

Clinicians should be aware of products available abroad because patients are returning from overseas trips with complications from injections of fillers not approved by the FDA. "I see a lot of people from the Pacific rim and Australia," he said. "What is astonishing to me is they have injectables, and they don't know what was injected into their face."

Dr. Matarasso has served as a consultant to Allergan and Medicis.

Juvéderm may cause slightlyless swelling, but there's not enough evidence to change products. DR. MATARASSO

PALM BEACH, FLA. — Technical tips to optimize use of injectable facial fillers and botulinum toxin were offered during a live patient demonstration at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

A natural-looking result is the goal. "We want to return patients to what they looked like when they were younger. That is what our patients want," Dr. Mark S. Nestor said. "Really, the idea is combining [products], such as Botox and some of these fillers, to get optimal results."

An initial patient assessment should include realistic expectations. Know what fillers can and cannot achieve. "What you see as a physician may be different than what a patient is concerned about. When you have done this for a while, it's interesting to look at why something bothers patients," said Dr. Nestor of Aventura, Fla.

Along with Dr. James M. Spencer and Dr. Joely Kaufman, Dr. Nestor treated a series of volunteers at the meeting with combined treatments of injectable fillers and botulinum toxin.

Treatment was halted for one person who experienced an adverse reaction. She was tilted back in the chair while ice was applied to her forehead. "She is having a vasovagal response, which is not that uncommon," Dr. Nestor said. "This happened in South Beach [at a meeting in February 2007]. Patients need to be laid back, and they will come out of it quickly."

The newest filler option is Perlane (hyaluronic acid, Medicis), which was approved by the Food and Drug Administration in May for correction of moderate to severe facial folds and wrinkles. Perlane's nonimmunogenic, stabilized hyaluronic acid gel particles are similar to Restylane (hyaluronic acid, Medicis) but larger. Perlane adds volume to restore surface contour in facial wrinkles and folds, including the nasolabial fold. The product should be injected into the deep dermis up to the superficial layer of the subcutis.

Dr. Nestor injected Perlane with a 27-G needle. "You can actually feel the filler going in. What you are seeing right away is the significant lift you get because this product is really robust."

After injecting the nasolabial folds, he massaged inside and outside of the mouth to get an even distribution, noting that "Perlane smooths out very, very nicely." The next step involved superficial injections of Restylane on top of the same area. He finished the treatment with botulinum toxin injections to the crow's feet area.

Perlane can also be injected to accentuate areas below the mouth, said Dr. Nestor, who disclosed a relationship with Medicis.

While treating another volunteer, he noted that Perlane can replace significant volume loss in the midcheek for an extended period. "It doesn't roll off. Studies have shown it can remain there 5 or 6 years."

In contrast, Dr. Nestor advised undercorrection of volume loss when using Juvederm Ultra (hyaluronic acid gel, Allergan). "The idea here is that you can always inject more. You don't want to inject too much to begin with." He typically injects the filler as he withdraws the syringe. "You can feel it going into the deeper aspect of the dermis."

Dr. Kaufman injected another volunteer with Juvederm. Another option would be Sculptra (poly-L-lactic acid, Sanofi-Aventis). "By using Sculptra, you would need less hyaluronic acid in the nasolabial folds," said Dr. Kaufman of the University of Miami. The direction of product flow can make a big difference. For marionette lines, for example, she injects downward toward the center of the face below a patient's mouth. In addition, one little bolus of hyaluronic acid right under the vermilion border on either side of the mouth "really turns the lip up," she said.

Another combination approach uses injection of Radiesse (calcium hydroxylapatite, BioForm Medical) to restore facial volume and botulinum toxin to lift the corners of the mouth, said Dr. Spencer, who has a skin cancer and cosmetic dermatology practice in St. Petersburg, Fla.

Dr. Spencer used a 27-G needle and a 1.3-cc syringe during the demonstration. Radiesse is "more viscous, so it takes a little more effort to inject," he said. Threading or serial puncture down are the two technique options. "I always see them back in a week to make sure everything is okay." He estimated that the volume enhancement with Radiesse will last 1-2 years.

Dr. Kaufman and Dr. Spencer had no relevant disclosures regarding the products used in the demonstration.

PALM BEACH, FLA. — Technical tips to optimize use of injectable facial fillers and botulinum toxin were offered during a live patient demonstration at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

A natural-looking result is the goal. "We want to return patients to what they looked like when they were younger. That is what our patients want," Dr. Mark S. Nestor said. "Really, the idea is combining [products], such as Botox and some of these fillers, to get optimal results."

An initial patient assessment should include realistic expectations. Know what fillers can and cannot achieve. "What you see as a physician may be different than what a patient is concerned about. When you have done this for a while, it's interesting to look at why something bothers patients," said Dr. Nestor of Aventura, Fla.

Along with Dr. James M. Spencer and Dr. Joely Kaufman, Dr. Nestor treated a series of volunteers at the meeting with combined treatments of injectable fillers and botulinum toxin.

Treatment was halted for one person who experienced an adverse reaction. She was tilted back in the chair while ice was applied to her forehead. "She is having a vasovagal response, which is not that uncommon," Dr. Nestor said. "This happened in South Beach [at a meeting in February 2007]. Patients need to be laid back, and they will come out of it quickly."

The newest filler option is Perlane (hyaluronic acid, Medicis), which was approved by the Food and Drug Administration in May for correction of moderate to severe facial folds and wrinkles. Perlane's nonimmunogenic, stabilized hyaluronic acid gel particles are similar to Restylane (hyaluronic acid, Medicis) but larger. Perlane adds volume to restore surface contour in facial wrinkles and folds, including the nasolabial fold. The product should be injected into the deep dermis up to the superficial layer of the subcutis.

Dr. Nestor injected Perlane with a 27-G needle. "You can actually feel the filler going in. What you are seeing right away is the significant lift you get because this product is really robust."

After injecting the nasolabial folds, he massaged inside and outside of the mouth to get an even distribution, noting that "Perlane smooths out very, very nicely." The next step involved superficial injections of Restylane on top of the same area. He finished the treatment with botulinum toxin injections to the crow's feet area.

Perlane can also be injected to accentuate areas below the mouth, said Dr. Nestor, who disclosed a relationship with Medicis.

While treating another volunteer, he noted that Perlane can replace significant volume loss in the midcheek for an extended period. "It doesn't roll off. Studies have shown it can remain there 5 or 6 years."

In contrast, Dr. Nestor advised undercorrection of volume loss when using Juvederm Ultra (hyaluronic acid gel, Allergan). "The idea here is that you can always inject more. You don't want to inject too much to begin with." He typically injects the filler as he withdraws the syringe. "You can feel it going into the deeper aspect of the dermis."

Dr. Kaufman injected another volunteer with Juvederm. Another option would be Sculptra (poly-L-lactic acid, Sanofi-Aventis). "By using Sculptra, you would need less hyaluronic acid in the nasolabial folds," said Dr. Kaufman of the University of Miami. The direction of product flow can make a big difference. For marionette lines, for example, she injects downward toward the center of the face below a patient's mouth. In addition, one little bolus of hyaluronic acid right under the vermilion border on either side of the mouth "really turns the lip up," she said.

Another combination approach uses injection of Radiesse (calcium hydroxylapatite, BioForm Medical) to restore facial volume and botulinum toxin to lift the corners of the mouth, said Dr. Spencer, who has a skin cancer and cosmetic dermatology practice in St. Petersburg, Fla.

Dr. Spencer used a 27-G needle and a 1.3-cc syringe during the demonstration. Radiesse is "more viscous, so it takes a little more effort to inject," he said. Threading or serial puncture down are the two technique options. "I always see them back in a week to make sure everything is okay." He estimated that the volume enhancement with Radiesse will last 1-2 years.

Dr. Kaufman and Dr. Spencer had no relevant disclosures regarding the products used in the demonstration.

PALM BEACH, FLA. — Technical tips to optimize use of injectable facial fillers and botulinum toxin were offered during a live patient demonstration at the annual meeting of the Florida Society of Dermatology and Dermatologic Surgery.

A natural-looking result is the goal. "We want to return patients to what they looked like when they were younger. That is what our patients want," Dr. Mark S. Nestor said. "Really, the idea is combining [products], such as Botox and some of these fillers, to get optimal results."

An initial patient assessment should include realistic expectations. Know what fillers can and cannot achieve. "What you see as a physician may be different than what a patient is concerned about. When you have done this for a while, it's interesting to look at why something bothers patients," said Dr. Nestor of Aventura, Fla.

Along with Dr. James M. Spencer and Dr. Joely Kaufman, Dr. Nestor treated a series of volunteers at the meeting with combined treatments of injectable fillers and botulinum toxin.

Treatment was halted for one person who experienced an adverse reaction. She was tilted back in the chair while ice was applied to her forehead. "She is having a vasovagal response, which is not that uncommon," Dr. Nestor said. "This happened in South Beach [at a meeting in February 2007]. Patients need to be laid back, and they will come out of it quickly."

The newest filler option is Perlane (hyaluronic acid, Medicis), which was approved by the Food and Drug Administration in May for correction of moderate to severe facial folds and wrinkles. Perlane's nonimmunogenic, stabilized hyaluronic acid gel particles are similar to Restylane (hyaluronic acid, Medicis) but larger. Perlane adds volume to restore surface contour in facial wrinkles and folds, including the nasolabial fold. The product should be injected into the deep dermis up to the superficial layer of the subcutis.

Dr. Nestor injected Perlane with a 27-G needle. "You can actually feel the filler going in. What you are seeing right away is the significant lift you get because this product is really robust."

After injecting the nasolabial folds, he massaged inside and outside of the mouth to get an even distribution, noting that "Perlane smooths out very, very nicely." The next step involved superficial injections of Restylane on top of the same area. He finished the treatment with botulinum toxin injections to the crow's feet area.

Perlane can also be injected to accentuate areas below the mouth, said Dr. Nestor, who disclosed a relationship with Medicis.

While treating another volunteer, he noted that Perlane can replace significant volume loss in the midcheek for an extended period. "It doesn't roll off. Studies have shown it can remain there 5 or 6 years."

In contrast, Dr. Nestor advised undercorrection of volume loss when using Juvederm Ultra (hyaluronic acid gel, Allergan). "The idea here is that you can always inject more. You don't want to inject too much to begin with." He typically injects the filler as he withdraws the syringe. "You can feel it going into the deeper aspect of the dermis."

Dr. Kaufman injected another volunteer with Juvederm. Another option would be Sculptra (poly-L-lactic acid, Sanofi-Aventis). "By using Sculptra, you would need less hyaluronic acid in the nasolabial folds," said Dr. Kaufman of the University of Miami. The direction of product flow can make a big difference. For marionette lines, for example, she injects downward toward the center of the face below a patient's mouth. In addition, one little bolus of hyaluronic acid right under the vermilion border on either side of the mouth "really turns the lip up," she said.

Another combination approach uses injection of Radiesse (calcium hydroxylapatite, BioForm Medical) to restore facial volume and botulinum toxin to lift the corners of the mouth, said Dr. Spencer, who has a skin cancer and cosmetic dermatology practice in St. Petersburg, Fla.

Dr. Spencer used a 27-G needle and a 1.3-cc syringe during the demonstration. Radiesse is "more viscous, so it takes a little more effort to inject," he said. Threading or serial puncture down are the two technique options. "I always see them back in a week to make sure everything is okay." He estimated that the volume enhancement with Radiesse will last 1-2 years.

Dr. Kaufman and Dr. Spencer had no relevant disclosures regarding the products used in the demonstration.

GRAPEVINE, TEX. — The outcomes of cosmetic dermatologic procedures are in the eyes of the beholders.

The mindset of expert evaluators and their level of blinding can play critical roles in how the results of a cosmetic procedure are judged, Dr. David Horne said at the annual meeting of the American Society for Laser Medicine and Surgery.

He tested this hypothesis in a "Rashomon"-like study in which the same set of before-and-after clinical images from a noninvasive dermatologic procedure performed on about 10 patients was presented to five different groups of evaluators. In each case, the evaluators reached different conclusions about the treatment's efficacy.

The first group of evaluators comprised enthusiasts for the procedure who were unblinded as to which images were taken before treatment and which were taken after. These experts judged the results as impressive, with all patients having at least 25% improvement, said Dr. Horne of New York-Presbyterian Hospital.

The experts in the second group were ambivalent about the procedure and were unblinded. They rated the images as showing modest benefit, with selected patients getting up to 25% improvement, he said.

The third group included experts who were skeptics of the procedure and were unblinded. They rated the images as showing minimal improvement, with several patients showing no response.

The fourth group was the same set of ambivalent experts as in group 2. They were reshown the images 3 months after their first assessment, but they were completely blinded as to which images were taken before treatment and which were made after treatment and this time they said that most patients were not changed by their treatment, and in some cases the treatment seemed to worsen their appearance.

The fifth group, the patients themselves, said that they all had at least a 20% improvement in appearance, with an average improvement of 50%, said Dr. Horne.

GRAPEVINE, TEX. — The outcomes of cosmetic dermatologic procedures are in the eyes of the beholders.

The mindset of expert evaluators and their level of blinding can play critical roles in how the results of a cosmetic procedure are judged, Dr. David Horne said at the annual meeting of the American Society for Laser Medicine and Surgery.

He tested this hypothesis in a "Rashomon"-like study in which the same set of before-and-after clinical images from a noninvasive dermatologic procedure performed on about 10 patients was presented to five different groups of evaluators. In each case, the evaluators reached different conclusions about the treatment's efficacy.

The first group of evaluators comprised enthusiasts for the procedure who were unblinded as to which images were taken before treatment and which were taken after. These experts judged the results as impressive, with all patients having at least 25% improvement, said Dr. Horne of New York-Presbyterian Hospital.

The experts in the second group were ambivalent about the procedure and were unblinded. They rated the images as showing modest benefit, with selected patients getting up to 25% improvement, he said.

The third group included experts who were skeptics of the procedure and were unblinded. They rated the images as showing minimal improvement, with several patients showing no response.

The fourth group was the same set of ambivalent experts as in group 2. They were reshown the images 3 months after their first assessment, but they were completely blinded as to which images were taken before treatment and which were made after treatment and this time they said that most patients were not changed by their treatment, and in some cases the treatment seemed to worsen their appearance.

The fifth group, the patients themselves, said that they all had at least a 20% improvement in appearance, with an average improvement of 50%, said Dr. Horne.

GRAPEVINE, TEX. — The outcomes of cosmetic dermatologic procedures are in the eyes of the beholders.

The mindset of expert evaluators and their level of blinding can play critical roles in how the results of a cosmetic procedure are judged, Dr. David Horne said at the annual meeting of the American Society for Laser Medicine and Surgery.

He tested this hypothesis in a "Rashomon"-like study in which the same set of before-and-after clinical images from a noninvasive dermatologic procedure performed on about 10 patients was presented to five different groups of evaluators. In each case, the evaluators reached different conclusions about the treatment's efficacy.

The first group of evaluators comprised enthusiasts for the procedure who were unblinded as to which images were taken before treatment and which were taken after. These experts judged the results as impressive, with all patients having at least 25% improvement, said Dr. Horne of New York-Presbyterian Hospital.

The experts in the second group were ambivalent about the procedure and were unblinded. They rated the images as showing modest benefit, with selected patients getting up to 25% improvement, he said.

The third group included experts who were skeptics of the procedure and were unblinded. They rated the images as showing minimal improvement, with several patients showing no response.

The fourth group was the same set of ambivalent experts as in group 2. They were reshown the images 3 months after their first assessment, but they were completely blinded as to which images were taken before treatment and which were made after treatment and this time they said that most patients were not changed by their treatment, and in some cases the treatment seemed to worsen their appearance.

The fifth group, the patients themselves, said that they all had at least a 20% improvement in appearance, with an average improvement of 50%, said Dr. Horne.

DESTIN, FLA. — Approval of Reloxin, a botulinum toxin type A product marketed in Europe as Dysport, is expected in the United States within the next 8-12 months, Dr. Patricia Farris said at a meeting sponsored by the Alabama Dermatology Society.

The product, which is similar to Botox, has been proved safe and effective in various trials worldwide, including in recently completed phase III U.S. trials, she said.

"The phase III clinical trial data for Reloxin in this country have not all been collated at this point, but I thank [Medicis Pharmaceutical Corp.] for sharing a little bit of it with me," said Dr. Farris, referring to the company that will develop and market Reloxin in the United States and which sponsored her talk at the meeting.

The 150-day, double-blind, placebo-controlled trial, which was designed to determine the efficacy of a single 50-unit dose for the treatment of glabellar lines, involved 300 patients. Response at 30 days in the 200 patients treated with Reloxin was excellent. "Slightly less than 90% of treated patients, compared with 0% of placebo patients, responded," said Dr. Farris of the department of dermatology at Tulane University, New Orleans.

Patients were considered responders if they improved from a score of 2 or 3 to a score of 0 or 1 on a 4-point scale, with 0 indicating no frown lines, 1 indicating mild frown lines, 2 indicating moderate frown lines, and 3 indicating severe frown lines.

Investigators used a 5-point injection technique, with two 10-unit injections in each of the corrugator muscles, and a single 10-unit injection in the procerus muscle. The 50-unit dose was shown in previous studies to be optimal. Median time to onset was 2 days, and by day 7 about 80% of patients had responded. Median duration was 117 days, Dr. Farris noted.

The product also proved to be safe. The most common adverse event was headache, and there were some ocular events, including two cases of probable Reloxin-related ptosis, she said.

DESTIN, FLA. — Approval of Reloxin, a botulinum toxin type A product marketed in Europe as Dysport, is expected in the United States within the next 8-12 months, Dr. Patricia Farris said at a meeting sponsored by the Alabama Dermatology Society.

The product, which is similar to Botox, has been proved safe and effective in various trials worldwide, including in recently completed phase III U.S. trials, she said.

"The phase III clinical trial data for Reloxin in this country have not all been collated at this point, but I thank [Medicis Pharmaceutical Corp.] for sharing a little bit of it with me," said Dr. Farris, referring to the company that will develop and market Reloxin in the United States and which sponsored her talk at the meeting.

The 150-day, double-blind, placebo-controlled trial, which was designed to determine the efficacy of a single 50-unit dose for the treatment of glabellar lines, involved 300 patients. Response at 30 days in the 200 patients treated with Reloxin was excellent. "Slightly less than 90% of treated patients, compared with 0% of placebo patients, responded," said Dr. Farris of the department of dermatology at Tulane University, New Orleans.

Patients were considered responders if they improved from a score of 2 or 3 to a score of 0 or 1 on a 4-point scale, with 0 indicating no frown lines, 1 indicating mild frown lines, 2 indicating moderate frown lines, and 3 indicating severe frown lines.

Investigators used a 5-point injection technique, with two 10-unit injections in each of the corrugator muscles, and a single 10-unit injection in the procerus muscle. The 50-unit dose was shown in previous studies to be optimal. Median time to onset was 2 days, and by day 7 about 80% of patients had responded. Median duration was 117 days, Dr. Farris noted.

The product also proved to be safe. The most common adverse event was headache, and there were some ocular events, including two cases of probable Reloxin-related ptosis, she said.

DESTIN, FLA. — Approval of Reloxin, a botulinum toxin type A product marketed in Europe as Dysport, is expected in the United States within the next 8-12 months, Dr. Patricia Farris said at a meeting sponsored by the Alabama Dermatology Society.

The product, which is similar to Botox, has been proved safe and effective in various trials worldwide, including in recently completed phase III U.S. trials, she said.

"The phase III clinical trial data for Reloxin in this country have not all been collated at this point, but I thank [Medicis Pharmaceutical Corp.] for sharing a little bit of it with me," said Dr. Farris, referring to the company that will develop and market Reloxin in the United States and which sponsored her talk at the meeting.

The 150-day, double-blind, placebo-controlled trial, which was designed to determine the efficacy of a single 50-unit dose for the treatment of glabellar lines, involved 300 patients. Response at 30 days in the 200 patients treated with Reloxin was excellent. "Slightly less than 90% of treated patients, compared with 0% of placebo patients, responded," said Dr. Farris of the department of dermatology at Tulane University, New Orleans.

Patients were considered responders if they improved from a score of 2 or 3 to a score of 0 or 1 on a 4-point scale, with 0 indicating no frown lines, 1 indicating mild frown lines, 2 indicating moderate frown lines, and 3 indicating severe frown lines.

Investigators used a 5-point injection technique, with two 10-unit injections in each of the corrugator muscles, and a single 10-unit injection in the procerus muscle. The 50-unit dose was shown in previous studies to be optimal. Median time to onset was 2 days, and by day 7 about 80% of patients had responded. Median duration was 117 days, Dr. Farris noted.

The product also proved to be safe. The most common adverse event was headache, and there were some ocular events, including two cases of probable Reloxin-related ptosis, she said.