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Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial.
J Am Acad Dermatol. 2020 Feb 14;:
Authors: Kirsch B, Smith S, Cohen J, DuBois J, Green L, Baumann L, Bhatia N, Pariser D, Liu PY, Chadha D, Walker P
Abstract
BACKGROUND: Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.
OBJECTIVE: To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.
METHODS: A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to one of three doses or vehicle, with daily treatment for 42 days. Coprimary endpoints were the percentage of participants exhibiting ≥1-point improvement in Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax; logistic regression), and change in HDSM-Ax as a continuous measure (ANCOVA). Pair-wise comparisons were one-sided with alpha=0.10.
RESULTS: At 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<0.05). 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≤0.0001). Most treatment-related adverse events were mild or moderate.
LIMITATIONS: Not powered to detect changes in gravimetric sweat production.
CONCLUSION: Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.
PMID: 32068049 [PubMed – as supplied by publisher]

