Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

Study Overview
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Brief Summary
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This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

Detailed Description
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This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.

Official Title
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A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: NAFT-600 (naftin 2 % gel)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test. For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate). Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s). Exclusion Criteria: Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina or myocardial infarction) within the last 6 months. Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. Subjects with a known hypersensitivity to study drugs or their components. Subjects who have a recent history or who are currently known to abuse alcohol or drugs. Uncontrolled diabetes mellitus. Hemodialysis or chronic ambulatory peritoneal dialysis therapy. Current diagnosis of immunocompromising conditions. Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis. Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection. Extremely severe tinea pedis (incapacitating). Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 12 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: NAFT-600 ( naftin 2 % gel)<br>Topical; applied once daily for two weeks | Drug: NAFT-600 (naftin 2 % gel)<br>* Topical; applied once daily for two weeks<br>* Other names: Naftin®;|
| Placebo Comparator: Placebo<br>Topical; applied once daily for two weeks. | Drug: Placebo<br>* Topical; applied once daily for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Cure of Interdigital Tinea Pedis | The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus. | Visit 4/ Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6 | Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture. | Visit 4/ Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fungal infection, athlete foot