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.
Multicenter, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines
Article first published online: 4 FEB 2013
© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.
Volume 39, Issue 4, pages 551–558, April 2013
How to Cite
Carruthers, A., Carruthers, J., Coleman, W. P., Donofrio, L., Flynn, T., Gold, M., Heinz, M., Harrington, L., Jones, D., McDaniel, D., Rohrer, T., Schlöbe, A., Solish, N. and Weiss, R. A. (2013), Multicenter, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines. Dermatologic Surgery, 39: 551–558. doi: 10.1111/dsu.12100
- Issue published online: 2 APR 2013
- Article first published online: 4 FEB 2013
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.
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.
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.
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.