Sofpironium Topical Gel Is Effective for Axillary Hyperhidrosis

Is sofpironium (Sofdra) topical gel effective for improving primary axillary hyperhidrosis?

The studies found that sofpironium topical gel 12.45% applied at bedtime significantly reduces sweat production and disease severity in patients 9 years and older with primary axillary hyperhidrosis. (Level of Evidence = 1b)

The investigators pooled results from two multicenter studies that evaluated the effectiveness of sofpironium topical gel for patients 9 years and older who were seeking treatment for primary axillary hyperhidrosis that occurred for a minimum of 6 months. A total of 701 eligible patients randomly received assignment to apply sofpironium topical gel 12.45% or vehicle gel once daily to each axilla at bedtime. The assessed coprimary outcome included a 2-point or greater improvement from baseline to the end of treatment on a previously validated primary axillary hyperhidrosis disease severity scoring tool (1-point change considered clinically meaningful) and at least a 70% reduction in measured sweat production. Individuals who assessed all outcomes remained masked to treatment group assignment. Complete follow-up occurred for 95.7% of participants at 6 weeks.

Using intention-to-treat analysis, the coprimary outcome occurred significantly more in the treatment group than in the control group (38.2% vs 17.7%, respectively; number needed to treat = 4.7; 95% CI, 3.7–7.4). Adverse events (eg, dry mouth, blurred vision, application site dermatitis) that led to study withdrawal also occurred significantly more often in the treatment group than in the control group (4.0% vs 0%).

Study design: Randomized controlled trial (double-blinded)

Funding source: Industry

Allocation: Concealed

Setting: Outpatient (any)

Reference: Pariser D, Glaser DA, Del Rosso J, et al. Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies. J Am Acad Dermatol. 2025;93(1):82-88.