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The Efficacy and Safety of a New U.S. BotulinumToxin Type A in the Retreatment of Glabellar LinesFollowing Open-Label Treatment

May 2009 | Volume 8 | Issue 5 | Original Article | 439 | Copyright © May 2009


Mark G. Rubin MD, Jeffrey S. Dover MD FRCPC FRCP,Richard G. Glogau MD, David J. Goldberg MD JD, Mitchel P.Goldman MD, Joel Schlessinger MD FAAD FAACS

Abstract

Introduction: A new U.S. Botulinum toxin type A (BoNT-A) has been shown to be safe and effective when administered once, but there is a paucity of clinical evidence regarding long-term use.
Objective: To evaluate the long-term efficacy and tolerability of repeated treatment with BoNT-A in the correction of moderate-tosevere glabellar lines.
Study Design/Methodology: Multicenter, phase 3, randomized, placebo-controlled, double-blind study comparing the efficacy of BoNT-A (50 units) with placebo upon re-treatment of glabellar lines following two-to-three cycles of open-label BoNT-A treatment in 311 patients.
Results: At endpoint, BoNT-A produced a significantly higher proportion of responders versus placebo. The incidence of treatmentemergent adverse effects (TEAEs) was slightly lower during additional treatment cycles; the frequency was comparable between BoNT-A and placebo groups.
Conclusion: Multiple treatment cycles of BoNT-A were well tolerated in the majority of patients, and there was no tachyphylaxis seen during the study duration of up to 23 months.