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Multicenter, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines

Authors


  • This study was funded by Merz Pharmaceuticals GmbH. Editorial assistance was provided by Ogilvy 4D, Oxford, UK. Alastair Carruthers, Jean Carruthers, William P. Coleman III, Lisa Donofrio, Timothy Flynn, Michael Gold, Moritz Heinz, Derek Jones, David McDaniel, Thomas Rohrer, Nowell Solish, and Robert Weiss are paid investigators in this Phase III trial. Andrea Schlöbe and Moritz Heinz are employees of Merz Pharmaceuticals GmbH, and Laura Harrington is an employee of Ogilvy 4D.

Address correspondence and reprint requests to: Alastair Carruthers, MD, Carruthers Clinical Research, Suite 820–943 West Broadway, Vancouver, BC V5Z 4E1, Canada, or e-mail: alastair@carruthers.net

Abstract

Background

Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins.

Objective

To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines.

Materials and Methods

Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration–mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120.

Results

Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated.

Conclusion

A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.

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