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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

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Conditions

Tinea Pedis

Locations

Kuchnir Dermatology and Dermatological Surgery

Framingham, Massachusetts 01701

United States

Kuchnir Dermatology and Dermatological Surgery

Milford, Massachusetts 01757

United States