NCT03135912

Three-Arm Trial of Novel Treatment for Tinea Pedis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: South End Skin Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Experimental Drug SESC 01	Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
DRUG	Placebo	Dosage method of SESC 01, without active ingredients.
DRUG	Terbinafine Hydrochloride	Topical terbinafine hydrochloride cream.

Timeline

• Start date: 2017-01-03
• Primary completion: 2017-08-02
• Completion: 2017-08-02
• First posted: 2017-05-02
• Last updated: 2017-10-06

Locations

1 site across 1 country: United States