NCT07245667PHASE2RecruitingAccepts Healthy Volunteers
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Propedix, Inc.
Start Date
12/30/2024
Completion Date
2/1/2026
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).
Detailed Description
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.
Eligibility Criteria
Age Range: 16 years to No maximum
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
Interventions
DRUG
1% Tolnaftate Stick Formula A
DRUG
1% Tolnaftate Stick Formula B
DRUG
1% Tolnaftate Stick Formula C
Conditions
Tinea Pedis
Locations
Kuchnir Dermatology and Dermatological Surgery
Framingham, Massachusetts 01701
United States
Kuchnir Dermatology and Dermatological Surgery
Milford, Massachusetts 01757
United States