Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study

NCT07245667 · tracked via the Priya Life Science USA tracker

Sponsor

Propedix, Inc.

Phase

Phase 2

Started

2024-12-30

Last updated

2025-11-28

Condition(s) studied

Tinea Pedis

Investigational drug(s) / intervention(s)

1% Tolnaftate Stick Formula A1% Tolnaftate Stick Formula B1% Tolnaftate Stick Formula C

1% Tolnaftate Stick Formula A: Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.

1% Tolnaftate Stick Formula B: Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.

1% Tolnaftate Stick Formula C: Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.

Study 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).

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Percentage of Subjects with a Complete Cure at Week 4 — Week 4
Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.

Trial sites (2)

Facility	City	Region	Status
Kuchnir Dermatology and Dermatological Surgery	Framingham	Massachusetts	Recruiting
Kuchnir Dermatology and Dermatological Surgery	Milford	Massachusetts	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07245667 on ClinicalTrials.gov ↗ ← All trials in the USA