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

Last updated: November 23, 2025
Sponsor: Propedix, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Yeast Infections

Athlete's Foot (Tinea Pedis)

Treatment

1% Tolnaftate Stick Formula B

1% Tolnaftate Stick Formula C

1% Tolnaftate Stick Formula A

Clinical Study ID

NCT07245667
PRO-TP-001
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female, aged 16 or above

  • Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology isacceptable)

  • Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (ForCohort 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 thestudy

Exclusion

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 thetrial

  • Known hypersensitivity to any ingredients of trial agents

  • Patients with a current diagnosis of diabetes or neuropathy

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: 1% Tolnaftate Stick Formula B
Phase: 2
Study Start date:
December 30, 2024
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Kuchnir Dermatology and Dermatological Surgery

    Framingham 4937230, Massachusetts 6254926 01701
    United States

    Active - Recruiting

  • Kuchnir Dermatology and Dermatological Surgery

    Milford 4943958, Massachusetts 6254926 01757
    United States

    Active - Recruiting

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