A Randomized, Double-Blind, Placebo-Controlled Study of Botulinum Toxin Type A for the Treatment of Glabellar Lines: Determination of Optimal Dose
Version of Record online: 2 JAN 2007
Volume 33, Issue Supplement s1, pages S51–S59, January 2007
How to Cite
MONHEIT, G., CARRUTHERS, A., BRANDT, F. and RAND, R. (2007), A Randomized, Double-Blind, Placebo-Controlled Study of Botulinum Toxin Type A for the Treatment of Glabellar Lines: Determination of Optimal Dose. Dermatologic Surgery, 33: S51–S59. doi: 10.1111/j.1524-4725.2006.32332.x
- Issue online: 2 JAN 2007
- Version of Record online: 2 JAN 2007
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≤ 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.