A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis.

Study Overview
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Brief Summary
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To evaluate and compare the safety and efficacy of TA103 in the treatment of tinea pedis.

Detailed Description
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A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing TA103 and the placebo control in the treatment of tinea pedis.

Official Title
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A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TA103 and Placebo Control in the Treatment of Tinea Pedis.

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: TA103
* Drug: Placebo Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non pregnant female aged ≥ 18 years Subjects must have provided IRB approved written informed consent Subjects must have clinical diagnosis of interdigital tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot (the non-interdigital lesions should not be hyperkeratotic, i.e., characteristic of tinea pedis moccasin). Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Subjects with a history of hypersensitivity or allergy to any of the study medication ingredients and its excipients. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA103<br>The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only. | Drug: TA103<br>* The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.<br>* Other names: Test Product;|
| Placebo Comparator: Placebo Control<br>The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only. | Drug: Placebo Control<br>* The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with complete cure at Week 6 (+/- 4 days) following treatment (study day 38-46) | To evaluate safety and efficacy of TA103 | Baseline to Week 6 Visit |