NCT07245667

Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study

Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Propedix, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).

Detailed description

To evaluate the efficacy and safety of 1% tolnaftate formulations delivered through novel stick-based vehicles in the treatment of subjects with potassium hydroxide (KOH)-positive tinea pedis.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	1% Tolnaftate Stick Formula A	Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
DRUG	1% Tolnaftate Stick Formula B	Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
DRUG	1% Tolnaftate Stick Formula C	Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-11-24
• Last updated: 2025-11-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study