A Randomized, Double‐Blind, Placebo‐Controlled Study of Botulinum Toxin Type A for the Treatment of Glabellar Lines

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

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