Three-Arm Trial of Novel Treatment for Tinea Pedis

South End Skin Care

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: Experimental Drug SESC 01; Drug: Terbinafine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03135912

SESK-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Experimental Treatment

Experimental group

Description:

Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.

Treatment:

Drug: Experimental Drug SESC 01

Vehicle Control

Placebo Comparator group

Description:

Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.

Treatment:

Drug: Placebo

Active Comparator

Active Comparator group

Description:

Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.

Treatment:

Drug: Terbinafine Hydrochloride