Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
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).
| Condition(s) | Tinea Pedis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 startin |
| Ages | 16 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Propedix, Inc. |
| Locations | Framingham, Massachusetts, United States; Milford, Massachusetts, United States |
| Start date | 2024-12-30 |
| NCT ID | NCT07245667 |
| Official listing | https://clinicaltrials.gov/study/NCT07245667 |