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

November 23, 2025 updated by: Propedix, Inc.

Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Framingham, Massachusetts, United States, 01701
        • Recruiting
        • Kuchnir Dermatology and Dermatological Surgery
        • Contact:
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Kuchnir Dermatology and Dermatological Surgery
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tolnaftate Stick Formula A
Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
Drug: 1% Tolnaftate Stick Formula A
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
Experimental: Tolnaftate Stick Formula B
Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks.
Drug: 1% Tolnaftate Stick Formula B
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
Experimental: Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.
Drug: 1% Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Propedix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-TP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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