A Phase 2 interventional study of 1% Tolnaftate Stick Formula A and 1% Tolnaftate Stick Formula B in Tinea Pedis, sponsored by Propedix, Inc.. Recruiting at 2 sites in United States. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Propedix, Inc. · Phase 2, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
Drug: 1% Tolnaftate Stick Formula A
Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
Drug: 1% Tolnaftate Stick Formula B
Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.
Drug: 1% Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.
Percentage of Subjects with a Complete Cure at Week 4
Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.
Time frame: Week 4
Plan to share: No — Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.
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