Efficacy and Safety Evaluation of a Novel Botulinum Toxin Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines
Article first published online: 6 DEC 2010
© 2010 by the American Society for Dermatologic Surgery, Inc.
Special Issue: Botulinum Toxins
Volume 36, Issue Supplement s4, pages 2111–2118, December 2010
How to Cite
BRANDT, F., O'CONNELL, C., CAZZANIGA, A. and WAUGH, J. M. (2010), Efficacy and Safety Evaluation of a Novel Botulinum Toxin Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines. Dermatologic Surgery, 36: 2111–2118. doi: 10.1111/j.1524-4725.2010.01711.x
- Issue published online: 6 DEC 2010
- Article first published online: 6 DEC 2010
BACKGROUND Botulinum toxin type A (BoNTA) is commonly injected to treat facial wrinkles. Complications include pain, erythema, bruising, and potential infection. RT001 Botulinum Toxin Type A Topical Gel (RT001) is under development for the treatment of lateral canthal lines (LCLs).
OBJECTIVE To assess the efficacy and safety of RT001 for the treatment of LCLs using a randomized, double-blind, repeat-dose, placebo-controlled study design.
METHODS & MATERIALS Healthy adult subjects were randomized to receive RT001 (N=19) or placebo (N=17) applied to their lateral canthal areas (LCAs). To evaluate safety of repeat exposure, treatment was administered at baseline and week 4. The primary efficacy measure was improvement in baseline LCL severity using the Investigator's Global Assessment of Lateral Canthal Line at Rest (IGA-LCL) Severity Scale.
RESULTS At 8 weeks, 19 (50%) LCAs treated with RT001 showed a 2-point or greater improvement in baseline IGA-LCL severity, versus none (0%) of the placebo-treated subjects (p<.001); 36 (94.7%) LCAs treated with RT001 showed a 1-point or more improvement in baseline IGA-LCL severity, versus five (14.7%) placebo-treated LCAs (p<.001). There were no treatment-related adverse events.
CONCLUSION RT001 was well tolerated and demonstrated an improvement in LCLs.
This study was sponsored by Revance Therapeutics, Inc., Newark, CA.