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Efficacy of IncobotulinumtoxinA for Treatment of Glabellar Frown Lines

A Post Hoc Pooled Analysis of 2 Randomized, Placebo-Controlled, Phase 3 Trials

Jones, Derek MD*; Carruthers, Jean MD; Narins, Rhoda S. MD; Coleman, William P. III MD§; Harrington, Laura PhD; Brandt, Fredric S. MD; Cohen, Joel L. MD#

doi: 10.1111/dsu.0000000000000001
Original Article
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BACKGROUND Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions.

OBJECTIVE To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies.

MATERIALS AND METHODS IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects, respectively. The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates (≥1-point improvement from baseline), mean score, and mean change from the baseline glabellar frown line severity score.

RESULTS At all follow-up visits, responder rates and mean change from the baseline score (investigator-assessed and subject-assessed) were significantly greater for incobotulinumtoxinA versus placebo (p < .0001). The maximum investigator-assessed responder rate (93.1%) was achieved at Day 30 after treatment, when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88. Treatment effect declined over time but the investigator-assessed responder rate was 45.7% at the end of the study.

CONCLUSION Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed. IncobotulinumtoxinA achieved a maximum responder rate of 93.1% and a long duration of treatment effect: 45.7% of subjects showed efficacy at 120 days.

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

Carruthers Clinical Research, Vancouver, BC, Canada;

Dermatology Surgery and Laser Center, White Plains, New York;

§Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana;

Ogilvy 4D, Oxford, United Kingdom;

Dermatology Research Institute, Coral Gables, Florida;

#AboutSkin Dermatology and DermSurgery, Englewood, Colorado

Address correspondence and reprint requests to: Derek Jones, MD, Skin Care and Laser Physicians of Beverly Hills, 9201 West, Sunset Boulevard, Suite 602, Los Angeles, CA 90069, or e-mail: derekjonesmd@gmail.com

D. Jones, J. Carruthers, R. S. Narins, W. P. Coleman III, F. S. Brandt, and J. L. Cohen have been consultants and/or investigators for Merz Pharmaceuticals GmbH. L. Harrington is a senior medical writer at Ogilvy 4D. Editorial assistance was provided by Ogilvy 4D, Oxford, United Kingdom, and funded by Merz Pharmaceuticals GmbH.

© 2014 by the American Society for Dermatologic Surgery, Inc. Published by Lippincott Williams & Wilkins
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