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IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study

Trevidic, Patrick MD*; Connolly, Simon A. MD; Biwer, Bernard MD; Ellers-Lenz, Barbara MSc§; Harrington, Laura S. PhD; Kestemont, Philippe MD; Noah, Ernst M. MD, PhD#; Sattler, Gerhard MD**; Weissenberger, Petra MD§; Kerscher, Martina MD, PhD††

doi: 10.1097/DSS.0000000000001416
Original Article

BACKGROUND In clinical practice, different upper facial areas are commonly treated together.

OBJECTIVE To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period.

MATERIALS AND METHODS In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of “none” or “mild” or a ≥1-point improvement in MAS scores.

RESULTS A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.

CONCLUSION IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

*Expert2Expert, Paris, France;

Regency Medical Clinic, Glasgow, United Kingdom;

Private Practice for Skin Diseases, Allergology and Aesthetic Dermatology, Ludwigshafen, Germany;

§Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany;

Ogilvy Healthworld, Oxford, United Kingdom;

Clinique Esthétique St George, Nice, France;

#Department for Plastic, Reconstructive and Aesthetic Surgery, Red Cross Hospital, Kassel, Germany;

**Rosenparkklinik, Darmstadt, Germany; and

††Division of Cosmetic Science, University of Hamburg, Hamburg, Germany

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

This study was sponsored by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Editorial assistance was provided by Ogilvy Healthworld, Oxford, United Kingdom and funded by Merz Pharmaceuticals GmbH. M. Kerscher has acted as a speaker/consultant for Merz, Kythera, and Q-Med/Galderma and has conducted clinical trials for Merz, Q-Med/Galderma, IPSEN, and Kythera. P. Trevidic has acted as a speaker for IPSEN, Merz, and Teoxane. S.A. Connolly has undertaken research studies for Allergan and Merz. He has received remuneration for this. He has also acted as a trainer for Allergan. P. Weissenberger is an employee of Merz Pharmaceuticals GmbH. B. Ellers-Lenz was an employee of Merz Pharmaceuticals GmbH at the time of the study. P. Kestemont has been a speaker for Galderma, IPSEN, Teoxane, Allergan, and Merz. E.M. Noah has acted as a consultant for Allergan and as a clinical investigator for Pfizer, Merz, Ethicon, Orbix, and IPSEN. G. Sattler has acted as a speaker for Merz, Allergan, and Galderma. The Rosenparkklinik has received research support and has conducted clinical trials for Merz, Galderma, and Allergan. The remaining authors have indicated no significant interest with commercial supporters.

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