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A Randomized, Double-Blind, Placebo-Controlled Study of Botulinum Toxin Type A for the Treatment of Glabellar Lines: Determination of Optimal Dose

Authors

  • GARY MONHEIT MD,

    1. Associate Clinical Professor, Departments of Dermatology and Ophthalmology, University of Alabama Medical Center, Birmingham, Alabama
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  • ALASTAIR CARRUTHERS MD,

    1. Associate Clinical Professor, Departments of Dermatology and Ophthalmology, University of Alabama Medical Center, Birmingham, Alabama
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  • FREDRIC BRANDT MD,

    1. Associate Clinical Professor, Departments of Dermatology and Ophthalmology, University of Alabama Medical Center, Birmingham, Alabama
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  • RHONDA RAND MD

    1. Associate Clinical Professor, Departments of Dermatology and Ophthalmology, University of Alabama Medical Center, Birmingham, Alabama
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Address correspondence and reprint requests to: Gary D. Monheit, Total Skin and Beauty Dermatology Center, PC, 2100 16th Avenue South, Ash Place Suite 202, Birmingham, AL 35205, or e-mail: monheitgd421@pol.net.

Abstract

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.

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