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OnabotulinumtoxinA for Treatment of Forehead and Glabellar Lines

Subject-Reported Satisfaction and Impact From a Phase 3 Double-Blind Study

Ogilvie, Patricia MD, PhD*; Rivkin, Alexander Z. MD; Dayan, Steven MD; Yoelin, Steven G. MD§; Weichman, Barry M. PhD; Garcia, Julie K. MS, PhD

doi: 10.1097/DSS.0000000000001779
Original Article
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BACKGROUND Patient-reported outcomes are important measures of treatment benefit in facial aesthetic medicine.

OBJECTIVE Evaluate prespecified subject-reported satisfaction and impact outcomes with onabotulinumtoxinA treatment of forehead lines (FHL) and glabellar lines (GL).

METHODS The study randomized (3:1) 391 adults with moderate to severe FHL and GL to onabotulinumtoxinA (FHL, 20 U; GL, 20 U) or placebo in double-blind period 1 (days 0–180); subjects could receive up to 2 additional onabotulinumtoxinA treatments in open-label period 2. Patient-reported outcomes were assessed using the validated Facial Line Satisfaction Questionnaire (FLSQ) and the 11-item Facial Line Outcomes (FLO-11) Questionnaire.

RESULTS The proportion of subjects mostly or very satisfied with treatment was significantly greater with onabotulinumtoxinA than with placebo (90.3% vs 1.0%; p < .0001). Responder rates on FLSQ Impact Domain (73.9% vs 18.9%), FLO-11 Item 1 (85.4% vs 3.6%), Item 4 (77.2% vs 11.2%), Item 5 (83.5% vs 7.8%), and total score (86.0% vs 6.9%) were significantly greater with onabotulinumtoxinA than with placebo on Day 30 (p < .0001). Responder rates favoring onabotulinumtoxinA in Period 1 were generally maintained with repeated treatment during Period 2.

CONCLUSION Subjects were highly satisfied with onabotulinumtoxinA treatment and reported significant improvements in appearance-related psychological and emotional impacts of their facial lines.

*Skin Concept, Munich, Germany;

David Geffen School of Medicine, UCLA, Los Angeles, California;

DeNova Research, Chicago, Illinois;

§Medical Associates Inc., Newport Beach, California;

Peloton Advantage, Parsippany, New Jersey;

Allergan plc, Irvine, California

Address correspondence and reprint requests to: Patricia Ogilvie, MD, PhD, Skin Concept, Theatinerstraße 46, Munich 80333, Germany, or e-mail: skin-concept@hotmail.de

This study was funded by Allergan plc, Dublin, Ireland. Editorial support for this article was provided by Peloton Advantage, Parsippany, New Jersey, and was funded by Allergan plc. P. Ogilvie has received research support or speaking/consultant fees from Allergan plc, Evolus, Inc., Galderma, Merz Aesthetics, and Revance. A.Z. Rivkin serves as a consultant and investigator for Allergan plc and Merz Aesthetics. S. Dayan has received research support or speaking/consultant fees from Allergan plc, Galderma, Merz Aesthetics, and Valeant. S.G. Yoelin serves as a consultant and investigator for Allergan plc. B.M. Weichman was employed by Peloton Advantage, which received funding from Allergan plc for medical editing and editorial support. J.K. Garcia is an employee of Allergan plc and owns stock/options in the company.

The opinions expressed in this article are those of the authors. The authors received no honoraria/fee or other form of financial support related to the development of this article.

© 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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