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Evaluation of Variable-Dose Treatment with a New U.S. Botulinum Toxin Type A (Dysport) for Correction of Moderate to Severe Glabellar Lines: Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

Kane, Michael A. C. M.D.; Brandt, Fredric M.D.; Rohrich, Rod J. M.D.; Narins, Rhoda S. M.D.; Monheit, Gary D. M.D.; Huber, M Barbara B.A.The Reloxin Investigational Group

Plastic and Reconstructive Surgery: November 2009 - Volume 124 - Issue 5 - p 1619-1629
doi: 10.1097/PRS.0b013e3181b5641b

Background: In April, the U.S. Food and Drug Administration approved a new U.S. formulation of botulinum neurotoxin type A (Dysport; Medicis Aesthetics, Inc., Scottsdale, Ariz.). This formulation has demonstrated inhibition of glabellar lines at a 50-unit dose. Standard clinical practice is to adjust the dose based on muscle mass.

Methods: Patients stratified by race/ethnicity were randomized to receive a single treatment of Dysport administered in various doses or placebo. Dysport was administered in a total volume of 0.4 to 0.6 ml for women (50, 60, or 70 units) and 0.5 to 0.7 ml for men (60, 70, or 80 units), based on procerus/corrugator muscle mass. Efficacy was assessed by a blinded evaluator and patient self-evaluation on days 14, 30, 60, 90, 120, and 150 after treatment.

Results: At day 30, 85 percent and 87 percent of Dysport-treated patients were responders as assessed by blinded evaluator and patient self-evaluation, respectively, compared with 3 percent and 5 percent of placebo-treated patients, respectively (p < 0.001). Median duration of effect was 109 days for Dysport versus 0 days for placebo (blinded evaluator) and 107 days for Dysport versus 0 days for placebo (patient self-evaluation). Response and duration of action were slightly higher in African American patients. The majority of treatment-emergent adverse events were mild or moderate in severity.

Conclusion: A single treatment with Dysport, with the dose based on gender and muscle mass, is well tolerated and provides a greater and longer-lasting improvement in glabellar lines compared with placebo.

New York and White Plains, N.Y.; Coral Gables, Fla.; Dallas, Texas; and Birmingham, Ala.

From the Manhattan Eye, Ear and Throat Hospital, the Dermatology Research Institute LLC, the University of Texas Southwestern Medical Center, New York Dermatology Surgery and Laser, and the Total Skin and Beauty Dermatology Center.

Received for publication March 25, 2009; accepted June 26, 2009.

Disclosures:Medicis Aesthetics, Inc. (Scottsdale, Ariz.) provided Dysport and study funding to the authors. Michael A. C. Kane is a consultant, speaker, stockholder, and investigator for Medicis; a consultant, speaker, and stockholder for Allergan; a consultant and stockholder for Mentor; a consultant and speaker for QMed; and a consultant, investigator, and stock option holder for Revance. F. Brandt is a consultant and investigator for Medicis; R. Narins is a former medical board member and investigator for QMed; a medical consultant and investigator for Medicis; a former medical consultant and investigator for Dermik; a medical consultant and stockholder for Bioform; a medical consultant and investigator for Merz; an investigator and past medical advisor for ColBar LifeScience; a medical consultant for OrthoNeutrogena Aesthetics; a consultant and investigator for Contura; a member of the medical board for Allergan; an investigator and consultant for Genzyme and Mentor; a consultant for Stiefel; a consultant and investigator for Revance; and a consultant and investigator for DDC. G. Monheit is a consultant and clinical investigator for Medicis, Ipsen, Galderma, Kythera, Genzyme, Dermik, Steifel, Merz, and Contura. Drs. Kane, Brandt, Rohrich, Narins, and Monheit are members of the Reloxin Investigational Group. M. Barbara Huber is a consultant and writer for Premier Healthcare Resource, Inc.

Michael A. C. Kane, M.D., 115 East 67th Street, New York, N.Y. 10065,

©2009American Society of Plastic Surgeons