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Safety of IncobotulinumtoxinA in the Treatment of Facial Lines: Results From a Pooled Analysis of Randomized, Prospective, Controlled Clinical Studies

Coleman, William P. III MD*; Sattler, Gerhard MD; Weissenberger, Petra MD; Hast, Michael A. PhD§; Hanschmann, Angelika MSc

doi: 10.1097/DSS.0000000000001409
Original Article

BACKGROUND The safety and efficacy of incobotulinumtoxinA in aesthetics has been established in multiple studies. Although individual studies have been reported, a combined assessment of incobotulinumtoxinA safety across studies is not available.

OBJECTIVE To assess the frequency of adverse events (AEs) across prospective incobotulinumtoxinA studies in aesthetics.

MATERIALS AND METHODS Safety data were assessed from 9 placebo-controlled or active-controlled single-dose studies on glabellar frown lines (GFL), crow's feet (CF), and upper facial lines (UFL). Analyses by treatment cycle included 4 repeat-dose studies on GFL and UFL.

RESULTS One thousand three hundred seventy-seven subjects received incobotulinumtoxinA (GFL, n = 1,189; CF, n = 83; UFL, n = 105) in single-dose studies (placebo-controlled studies: incobotulinumtoxinA, n = 866; placebo, n = 395). Over 1,000 subjects received incobotulinumtoxinA in repeat-dose studies (GFL, n = 880; UFL, n = 290). In placebo-controlled single-dose studies, incidences of treatment-related AEs ranged from 5.4% (GFL) to 22.9% (UFL). The most frequent treatment-related AE in single-dose studies was headache (GFL, 4.8%; UFL, 11.4%). In repeat-dose studies, incidence of AEs was highest during cycle 1 (GFL, 8.9%; UFL, 17.2%) and decreased across treatment cycles. No serious treatment-related AEs were observed.

CONCLUSION Results confirm the favorable safety and tolerability of incobotulinumtoxinA. The frequency of treatment-related AEs was low and may decrease with subsequent treatments.

*Coleman Cosmetic Dermatologic Surgery Center, Metairie, Louisiana;

Rosenpark Klinik, Darmstadt, Germany;

Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany;

§Merz North America, Inc., Raleigh, North Carolina

Address correspondence and reprint requests to: Michael A. Hast, PhD, Merz North America, Inc., 6501 Six Forks Road, Raleigh, NC 27615, or e-mail:

W.P. Coleman III and G. Sattler have been consultants and/or investigators for Merz. P. Weissenberger and A. Hanschmann are employees of Merz Pharmaceuticals GmbH. M.A. Hast is an employee of Merz North America, Inc.

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