Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Patient-reported outcomes from the ATMOS-1 and ATMOS-2 phase III randomized controlled trials
American Journal of Clinical Dermatology Nov 02, 2018
Pariser DM, et al. – In this study, researchers examined patient-reported outcomes (PROs) from replicate, randomized, double-blind, vehicle-controlled, phase 3 trials assessing the impact of glycopyrronium tosylate (GT) on primary axillary hyperhidrosis. A total of 463 patients were randomized to GT and 234 to vehicle, of whom 426 and 225 completed the trials, respectively. At baseline, participants used the Axillary Sweating Daily Diary (ASDD) to score their axillary sweating (using domains of severity, impact, and bothersomeness). They found that GT reduced the disease burden of primary axillary hyperhidrosis. For GT, the improvement was substantially greater than for vehicle at every study week. In addition, at week 4, they noted an improvement in the ASDD scores from baseline by 62.6& vs 34.0% (severity), 65.5% vs 40.3% (impact), and 65.4% vs 39.0% (bothersomeness). Moreover, the investigators observed improvements favoring GT with respect to Weekly Impact items, Patient Global Impression of Change, Hyperhidrosis Disease Severity Scale, and Dermatology Life Quality Index.
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