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Revance Therapeutics Announces Initiation of Phase Ib Clinical Trial of Topically Applied Botulinum Toxin Type A Gel for the Treatment of Facial Aesthetics

Posted on: Thursday, 9 November 2006, 06:00 CST

Revance Therapeutics, Inc. (Revance), today announced it has initiated a Phase Ib clinical trial of the Company's lead drug candidate, a topically delivered botulinum toxin type A gel for the treatment of facial lines and wrinkles. The randomized, placebo-controlled, clinical trial is designed to evaluate clinical response rates in patients with moderate to severe lateral canthal lines ("crow's feet").

"We believe our integrated macromolecule delivery and botulinum toxin platforms represent a major advancement in facial aesthetics," said Dan Browne, president and CEO of Revance. "Clinical trials designed to demonstrate that topically applied botulinum toxin dose forms can be targeted and focally delivered without needles to measurably reduce wrinkles and preserve facial expression will clearly differentiate the advantages of topical versus injectable. We look forward to the results from this clinical study and other controlled clinical studies of our toxin drug candidates for multiple aesthetic and therapeutic indications."

Potential indications for this topical botulinum toxin type A drug product include cosmetic, severe underarm, plantar and palm sweating, neurological, and immunomodulation indications.

Phase Ib Clinical Trial Protocol

The Phase Ib randomized, placebo-controlled, clinical trial will enroll subjects with moderate to severe lateral canthal lines and wrinkles ("crow's feet"). Study participants will be randomized into seven different treatment groups to evaluate the safety and clinical effect of a topical dose of botulinum toxin type A compared to placebo. Building on the findings of earlier preclinical and clinical trials, this trial will evaluate the clinical efficacy of topically applied dose of botulinum toxin to lateral canthal lines and wrinkles, and the clinical results seen at sequential follow-up intervals.

This study will evaluate composite measurements and photographs of improvement in fine lines and wrinkles derived from parameters such as the investigator's rating of line severity, the subject's global assessment of change, and the safety and tolerability of topically administered botulinum toxin type A along lateral canthal lines and wrinkles.

About Revance Therapeutics

Revance Therapeutics, Inc. ("Revance") is a private biopharmaceutical company dedicated to the discovery, development and commercialization of novel biopharmaceuticals for improving aesthetics and personal well-being. Revance was founded to develop proprietary drug candidates and dermal contouring therapies, which are safer and more effective than currently available injectable botulinum toxin products. These next-generation drug candidates could potentially advance patient care and improve consumer satisfaction in the rapidly growing $1 billion botulinum toxin and the $14 billion facial aesthetic markets. Revance's investors include Essex Woodlands Health Ventures, Vivo Ventures, Technology Partners, Palo Alto Investors and Shepherd Ventures.

Editor's Note: For more information about Revance Therapeutics or to speak with Dan Browne, please contact Pam Wadler or Nancy Trent at 212-966-0024.

Source: Business Wire

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