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NCT Number: NCT07245667

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

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).

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kuchnir Dermatology and Dermatological Surgery, Framingham, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% Tolnaftate Stick Formula A

Drug

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

1% Tolnaftate Stick Formula B

Drug

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

1% Tolnaftate Stick Formula C

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prinicipal Investigator

CONTACT

[email protected]

617-869-0126

Sponsors and collaborators

Lead sponsor

Propedix, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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