In clinical practice, different upper facial areas are commonly treated together.
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.
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.
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.
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: email@example.com
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.