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Three-Arm Trial of Novel Treatment for Tinea Pedis

NCT ID: NCT03135912

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2017-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Tinea Pedis

Keywords

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Tinea Pedis Athlete's Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Treatment

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

Group Type EXPERIMENTAL

Experimental Drug SESC 01

Intervention Type DRUG

Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.

Vehicle Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosage method of SESC 01, without active ingredients.

Active Comparator

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

Group Type ACTIVE_COMPARATOR

Terbinafine Hydrochloride

Intervention Type DRUG

Topical terbinafine hydrochloride cream.

Interventions

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Experimental Drug SESC 01

Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.

Intervention Type DRUG

Placebo

Dosage method of SESC 01, without active ingredients.

Intervention Type DRUG

Terbinafine Hydrochloride

Topical terbinafine hydrochloride cream.

Intervention Type DRUG

Other Intervention Names

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Lamisil AT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South End Skin Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Schanbacher, MD

Role: PRINCIPAL_INVESTIGATOR

South End Skin Care

Locations

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Kuchnir Dermatology & Dermatologic Surgery

Milford, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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SESK-001

Identifier Type: -

Identifier Source: org_study_id