Three-Arm Trial of Novel Treatment for Tinea Pedis

• Sponsor: South End Skin Care (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03135912
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 13

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: Experimental Drug SESC 01; Drug: Placebo; Drug: Terbinafine Hydrochloride	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Three-Arm Trial of Novel Treatment for Tinea Pedis
• Actual Study Start Date: Jan 3, 2017
• Actual Primary Completion Date: Aug 2, 2017
• Actual Study Completion Date: Aug 2, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Effective Treatment (Mycological Cure and Minimal Symptoms) [6 weeks]

   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.

Secondary Outcome Measures

1. Rate of Adverse Events [6 weeks]

   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.

2. Effective Treatment (Mycological Cure and Minimal Symptoms) [4 weeks]

   Effective treatment as defined above, but measured at the end of treatment (4 weeks after the beginning of participation).

3. Patient Satisfaction Score [4 weeks]

   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. Self-Reported Patient Compliance [4 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuchnir Dermatology & Dermatologic Surgery	Milford	Massachusetts	United States	01757

Sponsors and Collaborators

• South End Skin Care

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: South End Skin Care
• ClinicalTrials.gov Identifier: NCT03135912
• Other Study ID Numbers: SESK-001
• First Posted: May 2, 2017
• Last Update Posted: Oct 6, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by South End Skin Care: Tinea Pedis; Athlete's Foot
• Additional relevant MeSH terms: Tinea; Tinea Pedis; Terbinafine

Study Results

No Results Posted as of Oct 6, 2017