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Efficacy and Safety of OnabotulinumtoxinA for Treating Crow's Feet Lines Alone or in Combination With Glabellar Lines

A Multicenter, Randomized, Controlled Trial

Moers-Carpi, Marion MD*; Carruthers, Jean MD; Fagien, Steven MD; Lupo, Mary MD§,‖; Delmar, Henry MD; Jones, Derek MD#; Somogyi, Christine RN**; Lee, Elisabeth MPH**; Lei, Xiaofang PhD**; MacKinnon, Suzanne MRes**; Davis, Paula G. PhD††; Yalamanchili, Ramana PhD, MBA††; Campo, Antoinette††; Beddingfield, Frederick C. III MD, PhD#,**

doi: 10.1097/DSS.0000000000000220
Original Article
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BACKGROUND This was the second study in a Phase 3 program treating crow's feet lines (CFL) with onabotulinumtoxinA.

OBJECTIVE To evaluate the efficacy and safety of onabotulinumtoxinA treatment of CFL alone or with glabellar lines (GL).

METHODS This multicenter, double-blind, placebo-controlled, repeat treatment, 7-month study randomized subjects with moderate-to-severe CFL and GL (maximum contraction) to onabotulinumtoxinA 44 U (CFL: 24 U, GL: 20 U; n = 305), onabotulinumtoxinA 24 U (CFL: 24 U, GL: placebo; n = 306), or placebo (n = 306). Coprimary end points were investigator-assessed and subject-assessed proportion of subjects achieving a CFL Facial Wrinkle Scale Grade of 0 or 1 (maximum smile; Day 30, Cycle 1). Additional efficacy end points and safety/adverse events (AEs) were evaluated.

RESULTS All primary and secondary end points were achieved; statistically significant differences favored onabotulinumtoxinA (p < .001, all comparisons vs placebo). Investigator and subject responder rates were: CFL, 54.9% and 45.8%; CFL + GL, 59.0% and 48.5%; and placebo, 3.3% (both), respectively. Responder rates on other end points also significantly favored onabotulinumtoxinA treatments. Most AEs were mild or moderate. Two subjects discontinued: 1 serious AE unrelated to treatment (myocardial infarction) and 1 treatment-related AE (injection site pain).

CONCLUSION OnabotulinumtoxinA was effective and well tolerated for treating moderate-to-severe CFL alone or in combination with GL.

*Private Clinic, Hautok, Munich, Germany;

Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada;

Private Practice, Boca Raton, Florida;

§Department of Dermatology, Tulane University School of Medicine, New Orleans, Louisiana;

Private Practice, New Orleans, Louisiana;

Centre de Chirurgie Esthétique du Cap d'Antibes, Cap d'Antibes, France;

#Division of Dermatology, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California;

**Allergan, Inc., Irvine, California;

††SCI Scientific Communications and Information, Parsippany, New Jersey.

Dr. Beddingfield and Ms. Somogyi are now at Kythera Biopharmaceuticals, Inc., Calabasas, California

Address correspondence and reprint requests to: Marion Moers-Carpi, MD, Private Clinic, Hautok, Residenzstr. 7, 80333, Munich, Germany, or e-mail: drmarion@hautok.de

Supported by Allergan, Inc., Irvine, California. Writing and editorial assistance to the authors was provided by SCI Scientific Communications & Information, Parsippany, New Jersey and was funded by Allergan, Inc., Irvine, California.

M. Moers-Carpi, J. Carruthers, S. Fagien, M. Lupo, H. Delmar, and D. Jones are consultants and/or investigators for Allergan, Inc. C. Somogyi, E. Lee, X. Lei, S. MacKinnon, and F. C. Beddingfield are employees of Allergan, Inc., and receive compensation in salary, as well as stock or stock options (or both), at the time the study was conducted. The remaining authors have indicated no significant interest with commercial supporters.

© 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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