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Three-Arm Trial of Novel Treatment for Tinea Pedis

NCT03135912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-10-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • South End Skin Care

    lead INDUSTRY

Principal Investigators

  • Carl Schanbacher, MD · South End Skin Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135912 on ClinicalTrials.gov