BE Study of Naftifine HCL

Study Overview
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Brief Summary
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The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Official Title
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A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Naftifine hydrochloride 2%
* Drug: Placebo
* Drug: Naftin® 2% (Naftifine hydrochloride 2%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females aged more than or equal to 18 years Clinical diagnosis of 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), and provisionally confirmed at baseline by a positive potassium hydroxide (KOH) wet mount preparation (i.e., skin scrapings from the target site are placed on a microscope slide with a drop of 10% KOH, and microscopic examination reveals segmented fungal hyphae) The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity) Exclusion Criteria: Pregnant or lactating or planning to become pregnant during the study period Use of antipruritics, including antihistamines, within 72 hours prior to entry into the study Use of topical corticosteroid, antibiotics or antifungal therapy within 2 weeks prior to entry into the study Use of systemic (e.g., oral or injectable) corticosteroid, antibiotics or antifungal therapy within 1 month prior to entry into the study Use of oral terbinafine or itraconazole within 2 months prior to entry into the study Use of immunosuppressive medication or radiation therapy within 3 months prior to entry into the study. Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface. Presence of any other infection of the foot or other disease process that might confound the treatment evaluation History of dermatophyte infections unresponsive to systemic or topical antifungal drugs Known hypersensitivity to Naftifine Hydrochloride or to any component of the formulation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftifine hydrochloride 2%<br>A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. | Drug: Naftifine hydrochloride 2%<br>* Topical application for two weeks<br>* Other names: Naftifine hcl;|
| Active Comparator: Naftin® 2% (Naftifine hydrochloride 2%)<br>A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. | Drug: Naftin® 2% (Naftifine hydrochloride 2%)<br>* Topical application for two weeks<br>* Other names: Naftifine hcl;|
| Placebo Comparator: Placebo vehicle cream.<br>A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. | Drug: Placebo<br>* Topical application for two weeks<br>* Other names: Vehicle cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure. | week 6 + 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure. | week 6 + 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Tinea pedis, Naftin