1% tolnaftate stick treatment for tinea pedis (athlete's foot)
Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
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 |
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Propedix, Inc. Industry-sponsored |
| Locations | 2 sites (Framingham, Massachusetts and 1 other locations) |
| Trial ID | NCT07245667 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Framingham, Massachusetts and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.