Long-Term Results for IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines

Authors


  • This study was supported by Merz Pharmaceuticals GmbH. Editorial assistance was provided by Ogilvy 4D, Oxford, UK. B. Rzany, MD, ScM, has received research support and honoraria and has conducted clinical trials with the following manufacturers and distributors of botulinum toxin: Allergan Inc., Galderma Pharma S.A., Ipsen Pharma, and Merz Pharmaceuticals GmbH. T. C. Flynn, MD, has received research support and honoraria and has conducted clinical trials with the following manufacturers of botulinum toxin: Allergan Inc., Medicis Pharmaceutical Corporation, Merz Pharmaceuticals GmbH, and Solstice Neurosciences LLC. He holds common stock in Allergan Inc. A. Schlöbe, MD, and M. Heinz are employees of Merz Pharmaceuticals GmbH.
  • The authors have indicated significant interest with commercial supporters.

Address correspondence and reprint requests to: Professor Berthold Rzany, MD, ScM, Klinik für Dermatologie, Charité Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany, or e-mail: berthold.rzany@charite.de

Abstract

Background

IncobotulinumtoxinA has been approved for treatment of glabellar frown lines (GFL) in the United States, all major European markets, South Korea, and Argentina and in Russia and Mexico for the treatment of mimic wrinkles and hyperkinetic facial lines, respectively.

Objectives

Prospective, 2-year, open-label, multicenter, repeat-dose, Phase III trial investigating the safety and efficacy of incobotulinumtoxinA for the treatment of GFL.

Methods

Subjects with moderate or severe GFL on the Facial Wrinkle Scale (FWS), enrolled from previous trials, were treated with 20 U of incobotulinumtoxinA per cycle (up to eight treatment cycles, treatment interval at least 85 days). Efficacy was measured according to the investigator-assessed percentage of responders on the FWS (subjects with a score of 0 or 1) at rest and maximum frown on Day 30 of each cycle, subject assessments, and onset and duration of treatment effect.

Results

In 796 subjects, 77% to 88% were responders at rest, and 79% to 90% were responders at maximum frown. Onset was rapid; subjects reported effects in the first few days after treatment. No new tolerability or safety concerns were reported.

Conclusions

IncobotulinumtoxinA injections were well tolerated and resulted in efficacy in the treatment of GFL for up to 2 years.

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