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Abstract
Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P < .05). Least-square mean (SE) changes in HDSM-Ax were −2.02 (0.14), −2.09 (0.14), 2.10 (0.14), and −1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.Not powered to detect changes in gravimetric sweat production.Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.
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