Three-Arm Trial of Novel Treatment for Tinea Pedis

Study Overview
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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.

Official Title
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Three-Arm Trial of Novel Treatment for Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Experimental Drug SESC 01
* Drug: Placebo
* Drug: Terbinafine Hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Pedis, Athlete's Foot