Recruiting
Phase 2

Tolnaftate

Sponsor:

Propedix, Inc.

Code:

NCT07245667

Conditions

Tinea Pedis

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Interventions

1% Tolnaftate Stick Formula A

1% Tolnaftate Stick Formula B

1% Tolnaftate Stick Formula C

Study Details

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

Study ID

NCT07245667

Start date

Dec 30, 2024

Status verified date

Nov, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

experimental: Tolnaftate Stick Formula C

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

Interventions

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.

Primary outcome measure

  • Percentage of Subjects with a Complete Cure at Week 4 [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Prinicipal Investigator

617-869-0126cschanbacher@propedix.com

Locations

Kuchnir Dermatology and Dermatological Surgery

Recruiting

Framingham, Massachusetts, United States, 01701

Contacts

Prinicipal Investigator

508-872-2220clinicalresearch@propedix.com

Kuchnir Dermatology and Dermatological Surgery

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Prinicipal Investigator

508-478-2610clinicalresearch@propedix.com

More Information

Sponsor

Propedix, Inc.

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • tinea pedis
  • athletes foot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Propedix, Inc. on 2025-11-28.