A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose.
BACKGROUND
Botulinum toxin is used to treat glabellar lines, but the optimal dose of Reloxin (Dysport, Ipsen Biopharm Ltd.) for this indication remains to be established.


OBJECTIVE
The objective was to evaluate three doses of Reloxin to determine its efficacy and safety in treating glabellar lines.


METHODS
Participants were given 20, 50, or 75 U of Reloxin, or placebo, injected across the glabella. Follow-up was on Days 7, 30, 60, 90, and 120. Adverse events were also elicited by telephone on Day 3.


RESULTS
From investigators' and participants' assessments at Day 30, there were significantly more responders in each Reloxin-treated group than placebo (p< or = 0.001). The 50-U dose was as effective as the 75-U dose, with a similar duration. The most common adverse events were mild headache and nasopharyngitis, occurring similarly in all groups.


CONCLUSIONS
Reloxin (Dysport/botulinum toxin type A) treatment resulted in a significant improvement in glabellar lines, and the 50-U dose was identified as optimal. All doses were well tolerated.
Monheit
Gary
G
Department of Dermatology, University of Alabama Medical Center, Birmingham, Alabama 35205, USA. monheitgd421@pol.net
Carruthers
Alastair
A
Brandt
Fredric
F
Rand
Rhonda
R
D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A