Topical Botulinum Gel in the Works

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.

WAIKOLOA, Hawaii — A novel topical gel formulation of botulinum toxin type A, now in the developmental pipeline, may expand the range of skin problems dermatologists can tackle with the neurotoxin.

"This is intriguing on a number of levels. I think topical therapy really could be a very good thing," Dr. Mark G. Rubin observed at the annual Hawaii Dermatology Seminar sponsored by Skin Disease Education Foundation.

The topical gel, being developed by Revance Pharmaceuticals, combines botulinum toxin type A with a proprietary carrier peptide that can transport the neurotoxin across the skin all the way down to the musculature.

"Without an injection we can give people results that are similar to what we see with Botox [onabotulinumtoxinA] or Dysport [abobotulinumtoxinA]," according to Dr. Rubin of the Lasky Skin Center in Beverly Hills, Calif., and the University of California, San Diego.

If the topical gel - now in early clinical trials - were eventually to win marketing approval, how might it fit into clinical practice? Certainly some patients dislike needles so much that they would prefer to sit in a physician's office with a gel on their skin for 20-30 minutes rather than get a 3-second injection and be on their way, but Dr. Rubin is unsure how many people fit that description.

There are, however, certain clinical situations where a topical preparation would offer unequivocal advantages - hyperhidrosis, for example. "Think how nice it would be to just rub a gel on instead of injecting somebody 25 times in the axilla," he said.

A topical gel would also make it easier to use the neurotoxin to treat wrinkles at difficult-to-inject sites, such as the lower eyelids.

But perhaps the most interesting potential application for a topical botulinum toxin gel is in improving the quality of the skin. Physicians who inject botulinum toxin type A have described associated reductions in skin oiliness, pore size, and facial flushing problems. Mini-doses of a topical preparation might achieve similar improvements in skin quality without the muscle weakness induced by injecting neurotoxin, the dermatologist speculated.

A 77-patient, placebo-controlled, dose-ranging clinical trial of topical botulinum gel for the treatment of crow's feet was presented last year. Participants received 1.65 ng of the neurotoxin combined with various doses of the carrier protein. Among those subjects whose neurotoxin was combined with at least 6 mcg of carrier there was an average 2-point improvement in lateral canthal lines on a 4-point scale.

"The results were fairly profound - certainly comparable to what you see with injectable Botox or Dysport," Dr. Rubin commented.

Last year in the United States 2.8 million injections of neurotoxins were performed, and more than 20,000 physicians injected Botox. Sales of injectable neurotoxins are forecast to increase by more than 15% annually, according to the dermatologist.

Dr. Rubin disclosed that he serves as a consultant to Revance and Medicis. SDEF and this news organization are owned by Elsevier.