Results of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Botulinum Toxin Type A Topical Gel for the Treatment of Moderate-to-Severe Lateral Canthal Lines
January 2012 | Volume 11 | Issue 1 | Original Article | 38 | Copyright © January 2012
Richard Glogau MD,a,b Andrew Blitzer MD DDS,c Fredric Brandt MD,d Michael Kane MD,e Gary D. Monheit MD,f Jacob M. Waugh MDG
aUniversity of California San Francisco, CA bPrivate Practice, San Francisco, CA cHead & Neck Surgical Group, New York, NY dDermatology Research Institute, LLC, Coral Gables, FL eManhattan Eye, Ear & Throat Institute, New York, New York fTotal Skin & Beauty Dermatology Center, Birmingham, AL gRevance Therapeutics, Inc., Newark, CA
Objectives: To assess the safety and efficacy of RT001 for the treatment of lateral canthal lines in a randomized, double-blind, placebo-controlled study.
Materials & Methods: Adult subjects were enrolled to receive a single treatment of RT001 (n=45) or placebo (n=45) applied topically in the lateral canthal area. The primary endpoint was the composite of the Investigator Global Assessment of Lateral Canthal Line Severity (IGA-LCL) and the Patient Severity Assessment of lateral canthal line severity (PSA) defined as a 2-point or greater improvement on both scales.
Results: At four weeks, 44.4 percent of subjects treated with RT001 achieved a 2-point or greater improvement on a rigorous composite of both the IGA-LCL and PSA scales compared to 0.0% for the placebo subjects (P<0.0001). At four weeks, 88.9 percent of subjects achieved clinically relevant improvement by investigator assessment. Adverse events were mild in severity and unrelated to study treatment.
Conclusions: RT001 appears to be a safe and well-tolerated treatment for improvement of lateral canthal lines.
J Drugs Dermatol. 2012;11(1):38-45.