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.
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.
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