Glycopyrronium tosylate cloth, an
anticholinergic drug, has been approved for the topical treatment of primary axillary
hyperhidrosis in the USA, but its effects in Japanese patients have not been previously investigated. This 4-week, randomized, double-blind, vehicle-controlled, multicenter study was conducted to evaluate the efficacy and safety of
glycopyrronium tosylate cloth for primary axillary
hyperhidrosis patients in Japan. Eligible patients, who were ≥9 years of age and had primary axillary
hyperhidrosis ≥6 months, with gravimetrically-measured sweat production ≥50 mg/5 min, and
Hyperhidrosis Disease Severity Scale ≥3 (moderate) were randomized 1:1:1 to once daily topical
glycopyrronium tosylate 3.75%, 2.5%, or vehicle. Overall, 497 patients (163 in the
glycopyrronium tosylate 3.75% group, 168 in the
glycopyrronium tosylate 2.5% group, and 166 in the vehicle group, hereinafter in this order) were randomized. Statistically higher proportions of patients in the
glycopyrronium tosylate groups achieved ≥2-point improvement in
Hyperhidrosis Disease Severity Scale and ≥50% reduction in sweat production from baseline versus vehicle at week 4 (51.6%, 41.1%, and 16.4%, respectively; p < 0.001 in both cases). Higher responder rates in the
glycopyrronium tosylate groups compared with the vehicle group occurred as early as week 1. The most common treatment-emergent adverse events in patients treated with
glycopyrronium tosylate were
photophobia,
mydriasis, thirst, and
dysuria. Most treatment-emergent adverse events were mild as determined by the investigators. The incidence of treatment-emergent adverse events leading to treatment modification was low in the three groups. The 4-week use of topical
glycopyrronium tosylate improved the patient-reported outcome measure
Hyperhidrosis Disease Severity Scale and objectively-evaluated sweat production with a favorable benefit/risk profile.