The use of daily, topical glycopyrronium tosylate (GT) over the course of 4 weeks reduces sweating severity and decreases sweat production in patients with primary axillary hyperhidrosis, according to results of 2 replicate, randomized, double-blind, vehicle-controlled, 4-week, phase 3 trials: ATMOS-1 (ClinicalTrials.gov identifier: NCT02530281) and ATMOS-2 (ClinicalTrials.gov identifier: NCT02530294). Results were published in the Journal of the American Academy of Dermatology.

Patients were randomly assigned in a 2:1 ratio to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks (ATMOS-1: GT group, n=229 and vehicle group, n=115; ATMOS-2: GT group, n=234 and vehicle group, n=119). The coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 of the Axillary Sweating Daily Diary and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety assessment included the occurrence of treatment-emergent adverse events.

On the basis of pooled data from both studies, which were consistent with individual trial results, significantly more GT-treated patients achieved an Axillary Sweating Daily Diary Item 2 response compared with vehicle-treated patients (59.5% vs 27.6%, respectively) and had reduced production of sweat from baseline (−107.6 mg/5 minutes vs −92.1 mg/5 minutes, respectively) at week 4 (P <.001 for both of the coprimary endpoints). Most of the treatment-emergent adverse events reported were mild or moderate in severity and were infrequently associated with treatment discontinuation.

The major limitations of the 2 studies included their short duration and the inherent challenges involved in gravimetrically evaluating sweat production.

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The investigators concluded that topical GT significantly reduced sweating severity and sweat production by week 4, which is consistent with a clinically meaningful benefit, with differences between the treatment groups reported as early as week 1. Topical once-daily GT appears to provide a noninvasive, well-tolerated treatment option for patients with primary axillary hyperhidrosis.

Reference

Glaser DA, Hebert AA, Nast A, et al. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials [published online July 9, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.07.002