CLINICAL QUESTION

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

BOTTOM LINE

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)

SYNOPSIS

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.