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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

Carruthers, Alastair MD1; Carruthers, Jean MD1; Coleman, William P. III MD2; Donofrio, Lisa MD3; Flynn, Timothy MD4; Gold, Michael MD5; Heinz, Moritz MSc6; Harrington, Laura PhD12; Jones, Derek MD7; McDaniel, David MD8; Rohrer, Thomas MD9; Schlöbe, Andrea MD6; Solish, Nowell MD10; Weiss, Robert A. MD, FAAD11

doi: 10.1111/dsu.12100
ORIGINAL ARTICLES
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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.

1Carruthers Clinical Research, Vancouver, British Columbia, Canada

2Coleman Clinical Research, Metairie, Louisiana,

3Savin Dermatology Center, New Haven, Connecticut,

4Cary Skin Center, Cary, North Carolina,

5Tennessee Clinical Research Center, Nashville, Tennessee,

6Merz Pharmaceuticals GmbH, Frankfurtam Main, Germany

7Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California,

8McDaniel Institute of Anti-Aging Research, Virginia Beach, Virginia,

9Skin Care Physicians, Chestnut Hill, Massachusetts,

10Cosmetic Dermatology Toronto Yorkville, Toronto, Ontario, Canada

11Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland,

12Ogilvy 4D, Oxford, UK

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

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.

© 2013 by the American Society for Dermatologic Surgery, Inc.
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