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Pediatric dermatology · Sep 2015
Multicenter Study Controlled Clinical TrialA Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.
- Dee Anna Glaser, David M Pariser, Adelaide A Hebert, Ian Landells, Chris Somogyi, Emily Weng, Mitchell F Brin, and Frederick Beddingfield.
- Department of Dermatology, Saint Louis University, St. Louis, Missouri.
- Pediatr Dermatol. 2015 Sep 1; 32 (5): 609-17.
ObjectiveTo evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis.MethodsThis 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed hyperhidrosis severity following the first two treatments using the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes.ResultsFifty-six (38.9%) participants underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. OnabotulinumtoxinA significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine patients (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of patients experienced a two-grade or more improvement at 4 and 8 weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152 days. Using quality of life measures, health outcomes improved markedly. Eight patients (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to onabotulinumtoxinA did not develop.ConclusionOnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis.© 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.
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