1% tolnaftate stick treatment for tinea pedis (athlete's foot)
Official title: Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
Run by Propedix, Inc. · NCT07245667 · Data updated 2026-11-12
This study will test three different 1% tolnaftate stick formulas to see if they are safe and help people aged 16 and older with tinea pedis (athlete's foot).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Propedix, Inc. Industry-sponsored |
| Locations | 2 sites (Framingham, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | December 30, 2024 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT07245667 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 16 or older with symptomatic tinea pedis and a positive KOH test (except certain cohort exceptions), who are not pregnant or breastfeeding and have not recently used topical or systemic antifungals.
✕Probably not a fit
Patients with moccasin-type tinea pedis, active pus/serous exudate, diabetes or neuropathy, recent antifungal use, pregnancy, breastfeeding, or known hypersensitivity are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label Phase 2 interventional study compares three novel stick-based 1% tolnaftate formulations for the topical treatment of potassium hydroxide (KOH)-positive tinea pedis. Adults and adolescents aged 16 and older with clinical and usually KOH-confirmed athlete's foot will apply one of the stick formulations per protocol and be followed for safety and clinical response. The trial excludes patients with moccasin-type disease, active pus/serous exudate, recent topical or systemic antifungal use, diabetes or neuropathy, pregnancy or breastfeeding, and known hypersensitivity to study ingredients. Outcomes focus on tolerability and measures of lesion improvement and mycological clearance.
Why it matters
Potential benefit: If successful, the stick formulations could offer a convenient, well-tolerated topical option that improves adherence and clears athlete's foot.
How similar studies have gone: Tolnaftate is a well-established topical antifungal with prior evidence of efficacy, but delivering it via a novel stick vehicle is relatively untested and represents a formulation-based innovation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged 16 or above * Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology is acceptable) * Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (For Cohort 4, a negative KOH test is acceptable) * Signed and dated informed consent form * Willingness to comply with study protocol and availability for the duration of the study Exclusion Criteria: * Diagnosis of moccasin-type tinea pedis * Presence of serous exudate or pus * Treatment with a topical antifungal in the past 2 weeks * Treatment with a systemic antifungal in the past 4 weeks * Concurrent immunosuppressive or antimicrobial therapy * Liver disease * Pregnancy or breastfeeding * Use any other antifungal therapy during trial or within three months of starting the trial * Known hypersensitivity to any ingredients of trial agents * Patients with a current diagnosis of diabetes or neuropathy
Where it's running
-
Kuchnir Dermatology and Dermatological Surgery
Framingham, Massachusetts, United States Recruiting -
Kuchnir Dermatology and Dermatological Surgery
Milford, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Prinicipal Investigator
- Email: cschanbacher@propedix.com
- Phone: 617-869-0126
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.