A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar lines: determination of optimal dose.

Monheit G, Carruthers A, Brandt F, Rand R.

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 AND MATERIALS: 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.

Dermatol Surg. 2007 Jan;33(1 Spec No.):S51-9.

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