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Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From a Randomized, Double-Blind, Placebo-Controlled, Phase III Study

Kerscher, Martina MD*; Rzany, Berthold MD, ScM; Prager, Welf MD; Turnbull, Catriona PhD§; Trevidic, Patrick MD; Inglefield, Christopher BSc, MBBS

doi: 10.1097/DSS.0000000000000450
Original Article
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BACKGROUND Treating upper facial lines (UFL)—a combination of glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)—is a common aesthetic practice.

OBJECTIVE To provide the first placebo-controlled evidence of the efficacy and safety of incobotulinumtoxinA for UFL.

METHODS Healthy subjects (≥18 years) with moderate-to-severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contraction were randomized to incobotulinumtoxinA or placebo. For incobotulinumtoxinA, 54 to 64 U were administered (GFL, 20 U; HFL, 10–20 U; LPL, 24 U). Investigator-assessed MAS scores were evaluated for each area at maximum contraction on Day 30, both separately (responder = score of “none” [0] or “mild” [1]) and combined (UFL; sum score ≤3). Adverse events were recorded until 120 ± 7 days after treatment.

RESULTS Overall, 156 subjects were treated (incobotulinumtoxinA: 105; placebo: 51). On Day 30 at maximum contraction, a significant (p ≤ .0001) effect of incobotulinumtoxinA versus placebo for GFL (84.5% vs 0.0%, respectively), HFL (70.9% vs 2.1%), LPL (64.1% vs 2.1%), and UFL combination (55.3% vs 0.0%) was demonstrated for investigator-assessed “none” or “mild” scores. Two cases of mild eyelid ptosis occurred with incobotulinumtoxinA.

CONCLUSION IncobotulinumtoxinA demonstrated significant efficacy in treating GFL, HFL, and LPL separately and combined, as well as a good safety profile.

*Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany;

Rzany & Hund Private Practice, Berlin, Germany;

Prager & Partner Private Practice, Hamburg, Germany;

§SCI Scientific Communications and Information, Oxford, United Kingdom;

Expert2Expert, Paris, France;

London Bridge Plastic Surgery & Aesthetic Clinic, London, United Kingdom

Address correspondence and reprint requests to: Martina Kerscher, MD, Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Martin Luther King Platz 6, 20146 Hamburg, Germany, or e-mail: martina.kerscher@uni-hamburg.de

Editorial assistance was provided by Scientific Communications & Information, Oxford, United Kingdom, and funded by Merz Pharmaceuticals GmbH, Frankfurt, Germany.

M. Kerscher has received research support and has conducted clinical trials for Merz Pharmaceuticals GmbH (as Head of the Division of Cosmetic Sciences, University of Hamburg, Germany) and has acted as a speaker and/or investigator for Merz, Kythera, Q-Med/Galderma, and Pierre Fabre. B. Rzany has acted as a speaker and/or advisor for IPSEN, Kythera, Merz, Q-Med/Galderma, Teoxane, and Sinclair. W. Prager has acted as a lecturer, advisor, and investigator for Merz, Galderma, and Allergan. P. Trevidic has acted as a speaker for IPSEN, Merz, and Teoxane. C. Inglefield has acted as an advisor and speaker for Merz, Syneron, Eternogen, and Q-Med/Galderma. C. Turnbull has 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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