Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams 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 Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Butenafine cream 1% manufactured by Taro
* Drug: Lotrimin Ultra (butenafine) 1%
* Drug: Butenafine Vehicle manufactured by Taro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Microbiologically confirmed clinical diagnosis of interdigital tinea pedis If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives). A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic). The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (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 mentagrophyte or Epidermophyton floccosum. Exclusion Criteria: Use of any of the following within the indicated timeline: Oral or injectable steroids 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 over-the-counter (OTC) topical antifungals 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 Investigator's 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: 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butenafine cream 1% (Taro)<br>Butenafine cream manufactured by Taro applied for 7 days | Drug: Butenafine cream 1% manufactured by Taro<br>* Treatment applied to affected area twice daily for 7 days<br>|
| Active Comparator: Lotrimin Ultra (butenafine) 1%<br>Lotrimin Ultra (butenafine) applied for 7 days | Drug: Lotrimin Ultra (butenafine) 1%<br>* Treatment applied to affected area twice daily for 7 days<br>|
| Placebo Comparator: Vehicle<br>Butenafine vehicle applied for 7 days | Drug: Butenafine Vehicle manufactured by Taro<br>* Treatment applied to affected area twice daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure - Superiority Analysis | Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative. | 42 days | 
| Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra | Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure). | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic Cure | Subject with clinical and mycological cure at day 7 | 7 days | 
| Mycologic Cure | Negative KOH and fungal culture at day 42 | 42 days | 
| Clinical Cure | The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom = Mild - obvious but minimal involvement = Moderate - something that is easily noted = Severe - quite marked Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2. | 42 days | 
| Safety and Adverse Event Profile |  | 42 days | 

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