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Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
RecruitingPhase 2Healthy volunteers welcome
Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
Who can join
Ages 16 and older · All sexes · Healthy volunteers welcome
Full eligibility 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
About the 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).
What is being tested
- 1% Tolnaftate Stick Formula A (drug)
- 1% Tolnaftate Stick Formula B (drug)
- 1% Tolnaftate Stick Formula C (drug)
Sponsor: Propedix, Inc. · Participants: 150 · Started: Dec 30, 2024
Contact the study team
- Prinicipal Investigator · Phone: 617-869-0126
Official record on ClinicalTrials.gov — NCT07245667
Locations in the U.S.
| Massachusetts | Kuchnir Dermatology and Dermatological Surgery, Framingham Kuchnir Dermatology and Dermatological Surgery, Milford |
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.