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Phase 2
Age: 16Years +
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ID07245667

Study of 1% Tolnaftate Stick Treatments for Athletes Foot Tinea Pedis Using New Applicator Methods

Led by Propedix, Inc. · Updated on 2025-11-28

150

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of several 1% tolnaftate formulations delivered through new stick-based applicators for treating tinea pedis, also known as athletes foot. This phase 2 clinical trial focuses on individuals diagnosed with potassium hydroxide KOH-positive tinea pedis to evaluate how well these topical treatments work and how safe they are to use. Participants will receive one of three different formulations of 1% tolnaftate in a stick applicator Formula A, Formula B, or Formula C. All three formulations are applied topically to the affected foot area twice daily for four weeks. The study does not use random assignment or blinding, and each group will use their assigned formulation throughout the treatment period. During the study, participants will be monitored for a complete cure at week 4, which is the primary outcome measure. They will need to comply with the study protocol and be available for the entire study duration. Safety and response to treatment will be assessed by clinical evaluations and microscopy confirmation. The total participation time includes the 4-week treatment and necessary follow-up visits to check for effectiveness and any side effects.

CONDITIONS

Brief Title

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

Research Team

P

Prinicipal Investigator

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