SB208 for the Treatment of Tinea Pedis

Study Overview
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Brief Summary
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This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.

Detailed Description
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A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.

Official Title
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A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: SB208 2%
* Drug: SB208 4%
* Drug: SB208 16%
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site Exclusion Criteria: Women who are pregnant or nursing or planning on becoming pregnant Subjects with onychomycosis or moccasin-type t. pedis Subjects using topical or systemic anti-fungal agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB208 2%<br>Apply once daily to one or both feet for 14 days | Drug: SB208 2%<br>* Apply once daily to one or both feet for 14 days<br>* Other names: NVN1000 4%;|
| Experimental: SB208 4%<br>Apply once daily to one or both feet for 14 days | Drug: SB208 4%<br>* Apply once daily to one or both feet for 14 days<br>* Other names: NVN1000 8%;|
| Experimental: SB208 16%<br>Apply once daily to one or both feet for 14 days | Drug: SB208 16%<br>* Apply once daily to one or both feet for 14 days<br>* Other names: NVN1000 32%;|
| Placebo Comparator: Vehicle Gel<br>Apply once daily to one or both feet for 14 days | Drug: Vehicle Gel<br>* Apply once daily to one or both feet for 14 days<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fungal culture result | Negative fungal culture from target lesion | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure | Amelioration of signs and symptoms of tinea pedis | 6 wks | 
| Mycological cure | No evidence of fungal infection based on skin scraping and culture | 6 wks |