Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis

Study Overview
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Brief Summary
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To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Official Title
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A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in Patients With Interdigital Tinea Pedis

Conditions
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Interdigital Tinea Pedis

Intervention / Treatment
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* Drug: Butenafine Hydrochloride 1%
* Drug: Butenafine Hydrochloride 1% B
* Drug: Butenafine Hydrochloride 1%
* Drug: Vehicle A
* Drug: Vehicle B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non lactating females 18 years of age or older. Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit, A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling A confirmed clinical diagnosis of interdigital tinea pedis. The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation). Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum. Exclusion Criteria: Use of any of the following within the indicated timeline: Oral or injectable steroids within four weeks of the study start. Any oral anti-fungals within 4 weeks of the study start. Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start. Any prescription or OTC topical antifungal on the feet within two weeks prior to study entry. Use of any antihistamines within 72 hours of the study start. Any known hypersensitivity to butenafine or other antifungal agents. Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butenafine Hydrochloride 1% A<br>1 | Drug: Butenafine Hydrochloride 1%<br>* Twice daily application for 7 days<br>|
| Experimental: Butenafine Hydrochloride 1% B<br>2 | Drug: Butenafine Hydrochloride 1% B<br>* Twice daily application for 7 days<br>|
| Active Comparator: Butenafine Hydrochloride 1%<br>3 | Drug: Butenafine Hydrochloride 1%<br>* Twice daily application for 7 days<br>* Other names: Lotrimin Ultra Cream;|
| Placebo Comparator: Vehicle A<br>4 | Drug: Vehicle A<br>* Twice daily application for 7 days<br>|
| Placebo Comparator: Vehicle B<br>5 | Drug: Vehicle B<br>* Twice daily application for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure | Patients with clinical cure and mycologic cure are considered therapeutic cures. | 42 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure | Patient will be considered a clincal cure if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2. | 42 days | 
| Mycologic Cure | Patient will be considered a mycological cure if the results of both the potassium hydroxide (KOH) and the fungal culture are negative. | 42 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Pedis, Interdigital