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Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3 Study

Fagien, Steven MD*; Cohen, Joel L. MD; Coleman, William MD; Monheit, Gary MD§; Carruthers, Jean MD; Street, James PhD; Larsen, Kristin E. PhD; Yushmanova, Irina MD#; Lei, Xiaofang PhD#; Lee, Elisabeth MBA, MPH#; Vitarella, Domenico PhD#; Mao, Cheri MS#

doi: 10.1097/DSS.0000000000001414
Original Article
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BACKGROUND Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies.

OBJECTIVE To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL).

MATERIALS AND METHODS A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire.

RESULTS The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated.

CONCLUSION OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

*Aesthetic Eyelid Plastic Surgery, Boca Raton, Florida;

AboutSkin Dermatology and DermSurgery, Greenwood Village, Colorado;

Coleman Center for Cosmetic Dermatologic Surgery, Metairie, Louisiana;

§Total Skin and Beauty Dermatology Center, Birmingham, Alabama;

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

Peloton Advantage, Parsippany, New Jersey;

#Allergan plc, Irvine, California

Address correspondence and reprint requests to: Steven Fagien, MD, Aesthetic Eyelid Plastic Surgery, 660 Glades Road, Suite 210, Boca Raton, FL 33431, or e-mail: sfagien@aol.com

This study was funded by Allergan plc. Editorial support was provided by J. Street and K.E. Larsen of Peloton Advantage, Parsippany, New Jersey, and was funded by Allergan plc. S. Fagien and J. Carruthers serve as investigators for Allergan plc. J.L. Cohen and W. Coleman serve as consultants and clinical trial investigators for Allergan plc. G. Monheit serves as an investigator for Allergan plc, Galderma, Alphaeon, and Teoxane and as a consultant for Allergan plc, Galderma, Suneva, and Merz. J. Street and K.E. Larsen are employees of Peloton Advantage, which received funding from Allergan plc for medical editing and editorial support. D. Vitarella, I. Yushmanova, E. Lee, X. Lei, and C. Mao are employees of Allergan plc and may own stock or options in the company.

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

© 2017 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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