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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Repeated OnabotulinumtoxinA Treatments in Subjects With Crow's Feet Lines and Glabellar Lines

Carruthers, Jean MD*; Rivkin, Alexander MD; Donofrio, Lisa MD‡,§; Bertucci, Vince MD, FRCPC; Somogyi, Chris RN; Lei, Xiaofang PhD; Davis, Paula G. PhD#; Campo, Antoinette#; Beddingfield, Frederick C. MD, PhD†,¶

doi: 10.1097/DSS.0000000000000357
Original Article
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BACKGROUND This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow's feet lines (CFL).

OBJECTIVE To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines (GL) in subjects with moderate-to-severe CFL and GL (maximum smile).

MATERIALS AND METHODS This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U (CFL only; n = 227) or 44 U (24 U for CFL + 20 U for GL; n = 260) to retreatment with the same dose. Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U (n = 101) or placebo (n = 96). Primary efficacy end point (Day 30) was the proportion of subjects who achieved a CFL severity rating of none or mild (maximum smile) on the investigator-assessed Facial Wrinkle Scale (FWS). Additional efficacy end points and adverse events were evaluated.

RESULTS Responder rates (primary end point) were significantly greater in onabotulinumtoxinA-treated groups (24 U: 56.5%; 44 U: 63.6%; placebo: 1.1%; p < .001). Improvements on most patient-reported outcomes (PROs) favored the 44-U group over the 24-U group. Adverse events did not differ among groups; most were mild or moderate.

CONCLUSION Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs. Adverse event profiles remain consistent with approved GL labeling.

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

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

Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut;

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

Division of Dermatology, University of Toronto, Toronto, Ontario, Canada;

Allergan, Inc., Irvine, California;

#SCI Scientific Communications & Information, Parsippany, New Jersey. C. Somogyi and F. C. Beddingfield are now at Kythera Biopharmaceuticals, Inc., Calabasas, California

Address correspondence and reprint requests to: Jean Carruthers Cosmetic Surgery Inc, 943 West Broadway, Suite 820, Vancouver, BC, Canada V5Z4E1; E-mail: drjean@carruthers.net

Sponsored by Allergan, Inc., Irvine, CA. Writing and editorial assistance was provided by SCI Scientific Communications & Information, Parsippany, NJ, and was funded by Allergan, Inc. Irvine, CA.

J. Carruthers and A. Rivkin are consultants and investigators for Allergan, Inc. L. Donofrio is an investigator for Allergan, Inc. V. Bertucci is a speaker, consultant, and investigator for Allergan, Inc. X. Lei is an employee of Allergan, Inc., and receives compensation in salary, as well as stock or stock options (or both). C. Somogyi and F. C. Beddingfield were employees of Allergan, Inc. at the time of this study and received compensation in salary, as well as stock or stock options (or both). The other 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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