Three-Arm Trial of Novel Treatment for Tinea Pedis

• Status: Completed
• Trial end date: 2017-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South End Skin Care
• Treatments: Terbinafine

Criteria

Inclusion Criteria:

• male or female, aged 18 or above

• clinical diagnosis of tinea pedis

• diagnosis confirmed with potassium hydroxide microscopy

• availability for the duration of the study (6 weeks)

• willingness to comply with study protocol

• informed consent

Exclusion Criteria:

• moccasin-type tinea pedis

• severe maceration of interdigital spaces

• severe fissuring

• history of dry feet, cracking, fissuring

• concurrent onychomycosis

• serous exudate or pus

• topical antifungal treatment in the past 2 weeks

• systemic antifungal treatment in the past 4 weeks

• concurrent immunosuppressive or antimicrobial therapy

• liver disease

• pregnancy or breastfeeding

• known hypersensitivity to any ingredients of trial agents