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 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. RESULTS 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. 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.

中文翻译：

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局部用溴化舒普龙铵凝胶治疗腋窝多汗症的疗效和安全性：II期随机，对照，双盲试验。

背景技术原发性腋窝多汗症具有有限的非侵入性，有效且耐受性良好的治疗选择。目的评估新型抗胆碱能溴化舒芬酸溴铵的局部治疗多汗症。方法II期，多中心，随机，对照，双盲研究。参与者被随机分配为3种剂量或媒介物中的1种，每天治疗42天。共同主要终点是通过逻辑回归分析显示的多汗症严重程度-腋窝评分（HDSM-Ax）得分改善≥1分的参与者百分比，以及通过协方差分析作为连续测量的HDSM-Ax评分的变化。成对比较为单侧，α= 0.10。结果在治疗结束时，分别有5％，10％，15％，70％，79％，76％和54％的参与者 车辆组的HDSM-Ax改善≥1点（P <.05）。HDSM-Ax中的最小二乘均方（SE）变化为-2.02（0.14），-2.09（0.14），2.10（0.14）和-1.30（0.14）（所有P≤.0001）。大多数与治疗相关的不良事件为轻度或中度。局限性没有能力检测重量汗液的变化。结论溴化索非罗铵凝胶可有效降低多汗症的严重程度，并具有可接受的安全性。