Efficacy and safety of topical sofpironium bromide in treating primary axillary hyperhidrosis: systematic review and meta-analysis of randomized controlled trials

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This systematic review and meta-analysis aimed to comprehensively evaluate the efficacy and safety of topical sofpironium bromide in patients with primary axillary hyperhidrosis (PAH) in various published randomized controlled trials (RCTs). The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We systematically searched PubMed, Scopus, Web of Science, Embase, and Medline databases through April 30, 2025, using keywords related to sofpironium and PAH. The odds ratio (OR) or mean difference (MD) was calculated using a random effects model with 95% confidence interval (CI). Three RCTs of sofpironium were included in the meta-analysis, with 1,209 patients with PAH. Sofpironium, compared to the vehicle, showed statistically significant improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score (OR=2.35, 95% CI [1.82 to 3.04]), Hyperhidrosis Disease Severity Scale (HDSS) score (OR=2.02, [1.46 to 2.79]), Dermatology Life Quality Index (DLQI) score (MD=-2.75, [-3.58 to -1.92]), and gravimetric sweat production (MD=-26.39, [-44.65 to -8.12]). The incidences of anticholinergic adverse events (AEs) and application site AEs were statistically higher in patients treated with sofpironium. Sofpironium is an effective treatment for PAH associated with significant improvements in sweat reduction and QOL for patients, although the drug also has risks of anticholinergic or application-site AEs.

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