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.

Summary

Across two double-blind phase 3 RCTs (n=701 pooled), sofpironium 12.45% gel significantly improved HDSS-Axillary-7 by ≥2 points and reduced gravimetric sweat versus vehicle, with good tolerability. Findings support once-daily bedtime application in patients ≥9 years with primary axillary hyperhidrosis.

Key Findings

• Significant pooled improvement in HDSS-Axillary-7 by ≥2 points versus vehicle (P < .0001).
• Greater reduction in gravimetric sweat production at end of treatment versus vehicle (P = .0002).
• Treatment was generally well-tolerated with short-term use over 6 weeks.

Clinical Implications

Consider sofpironium 12.45% gel as a first-line topical option for primary axillary hyperhidrosis in patients ≥9 years, with bedtime application and monitoring for anticholinergic effects.

Limitations

• Short treatment duration and follow-up limit long-term efficacy and safety assessment.
• Generalizability to non-axillary hyperhidrosis or comorbid populations is not established.

Future Directions

Longer-term safety/effectiveness studies, head-to-head comparisons with other topicals or devices, and real-world outcomes in diverse populations.