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

NCT07245667 | Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO-TP-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Tinea Pedis

Keywords

tinea pedis; athletes foot

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects with a Complete Cure at Week 4

  Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.

  Week 4

Study Arms (3)

Tolnaftate Stick Formula A

EXPERIMENTAL

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

Tolnaftate Stick Formula B

EXPERIMENTAL

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

Tolnaftate Stick Formula C

EXPERIMENTAL

Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.

Drug: 1% Tolnaftate Stick Formula C

Interventions

1% Tolnaftate Stick Formula A DRUG

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

Tolnaftate Stick Formula A

1% Tolnaftate Stick Formula B DRUG

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

Tolnaftate Stick Formula B

1% Tolnaftate Stick Formula C DRUG

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

Tolnaftate Stick Formula C

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Propedix, Inc.: lead

Study Sites (2)

Kuchnir Dermatology and Dermatological Surgery

Framingham, Massachusetts, 01701, United States

RECRUITING

Kuchnir Dermatology and Dermatological Surgery

Milford, Massachusetts, 01757, United States

RECRUITING

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Prinicipal Investigator

CONTACT

617-869-0126; cschanbacher@propedix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 30, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)