Efficacy and Safety Evaluation of a Novel Botulinum Toxin Topical Gel for the Treatment of Moderate to Severe Lateral Canthal Lines

Dermatologic Surgery (Impact Factor: 2.11). 11/2010; 36(s4):2111 - 2118. DOI: 10.1111/j.1524-4725.2010.01711.x
Source: PubMed


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.

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Available from: Jacob M Waugh, Apr 02, 2014
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    • "Topical BTXs continue to be investigated mainly in Mexico and North America. A novel gel delivery system is also available, which has been developed for delivering a 150 kDa BTX-A formulation (developed by Revance Therapeutics, Inc., Newark, CA, USA) Studies have so far mainly focused on treating axillary hyperhidrosis and crow’s feet areas [23], with this formulation showing effective and very promising results. Studies comparing the efficiency and duration compared with injectable BTX-A will be of interest. "
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