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.
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.


CONCLUSIONS
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.
Kane
Michael A C
MAC
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.
Brandt
Fredric
F
Rohrich
Rod J
RJ
Narins
Rhoda S
RS
Monheit
Gary D
GD
Huber
M Barbara
MB
D000328:Adult; D001741:Black or African American / Q000706:statistics & numerical data; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005152:Facial Muscles / Q000187:drug effects* / Q000473:pathology*; D005260:Female; D005546:Forehead / Q000473:pathology; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A