Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis

Study Overview
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Brief Summary
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The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.

Official Title
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A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Naftifine Hydrochloride Cream 2%
* Drug: Naftin® (Naftifine Hydrochloride) Cream 2%
* Drug: Placebo Topical Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating females 18 years or older 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 presence of interdigital tinea pedis infection 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 Exclusion Criteria: Females who are pregnant, lactating or planning to become pregnant during the study period Use of antipruritics, including antihistamines within 72 hours prior to baseline visit Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit Use of oral terbinafine or itraconazole within two months prior to baseline visit Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation Past history of dermatophyte infections with a lack of response ot antifungal therapy

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 Cream 2%<br>Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) | Drug: Naftifine Hydrochloride Cream 2%<br>* Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks<br>* Other names: Naftifine;|
| Active Comparator: Naftin® Cream 2%<br>Naftin® (Naftifine Hydrochloride) Cream 2% | Drug: Naftin® (Naftifine Hydrochloride) Cream 2%<br>* Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.<br>* Other names: Naftifine;|
| Placebo Comparator: Placebo Topical Cream<br>Placebo Topical Cream | Drug: Placebo Topical Cream<br>* Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.<br>* Other names: vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure | The proportion of subjects with therapeutic cure (both mycological cure and clinical cure) at the test-of-cure visit conducted four weeks after the end of treatment. | 6 weeks | 

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