drugset / Trial / NCT03135912

Three-Arm Trial of Novel Treatment for Tinea Pedis

NCT03135912

Phase 2 Completed 90 enrolled South End Skin Care
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.

Timeline

Start
2017-01-03
Primary completion
2017-08-02
Completion
2017-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SESC 01 Unknown Topical
Comparator Terbinafine Small molecule Topical

Indications