Three-Arm Trial of Novel Treatment for Tinea Pedis

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Experimental Drug SESC 01; Drug: Placebo; Drug: Terbinafine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • Kuchnir Dermatology & Dermatologic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Treatment; Patients supplied with Experimental Drug SESC 01 for daily topical therapy for 4 weeks.	Drug: Experimental Drug SESC 01; Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
Placebo Comparator: Vehicle Control; Patients supplied with inactive vehicle (placebo), identical to experimental treatment but without active ingredients, to be applied daily for 4 weeks.	Drug: Placebo; Dosage method of SESC 01, without active ingredients.
Active Comparator: Active Comparator; Terbinafine hydrochloride cream, to be applied twice daily for 4 weeks.	Drug: Terbinafine Hydrochloride; Topical terbinafine hydrochloride cream.; Other Names: Lamisil AT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Treatment (Mycological Cure and Minimal Symptoms)	Binary outcome measure defined as mycological cure AND a total clinical assessment score less than or equal to 2 (out of a possible 18). Mycological cure is defined as negative potassium hydroxide microscopy, while the clinical assessment is based on a sum of 6 symptoms (desquamation, vesiculation, erythema, fissuring, maceration, and pruritus) scored 0-3 by a physician.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse Events	To examine treatment safety, we will calculate the rate of adverse events and serious adverse and compare them between the study's three arms using Chi-square tests to evaluate whether a statistically significant difference is present.	6 weeks
Effective Treatment (Mycological Cure and Minimal Symptoms)	Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).	4 weeks
Patient Satisfaction Score	At the conclusion of treatment, patients complete a brief survey on their impressions of the treatment's tolerability, effectiveness, and convenience on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = excellent, or they may answer with "No answer/prefer not to say". Scores will be compared for each of the three characteristics and as a sum of the three scores.	4 weeks
Self-Reported Patient Compliance	On the same experience questionnaire, patients are asked to estimate how many doses of treatment they missed or forgot to take. Possible answers are None, 1-2, 3-4, 5-6, 7-8, or 9 or more. This indicates whether there is a significant difference in patients' likelihood to adhere to a treatment regimen.	4 weeks

Collaborators and Investigators

• Sponsor: South End Skin Care
• Investigators: Principal Investigator: Carl Schanbacher, MD, South End Skin Care

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): August 2, 2017
• Study Completion (Actual): August 2, 2017

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Tinea Pedis; Athlete's Foot
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Terbinafine
• Other Study ID Numbers: SESK-001