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

Phase 1

Completed

Interventions: Drug: Butenafine Vehicle manufactured by Taro
Drug: Butenafine cream 1% manufactured by Taro
Drug: Lotrimin Ultra (butenafine) 1%

Brief Summary: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Vehicle	Butenafine Vehicle manufactured by Taro	Butenafine vehicle applied for 7 days
Butenafine cream 1% (Taro)	Butenafine cream 1% manufactured by Taro	Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) 1%	Lotrimin Ultra (butenafine) 1%	Lotrimin Ultra (butenafine) applied for 7 days

Primary Outcome Measures

Name	Time	Method
Therapeutic Cure - Superiority Analysis	42 days	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.
Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra	42 days	Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).

Secondary Outcome Measures

Name	Time	Method
Therapeutic Cure	7 days	Subject with clinical and mycological cure at day 7
Mycologic Cure	42 days	Negative KOH and fungal culture at day 42
Clinical Cure	42 days	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 1. = Mild - obvious but minimal involvement 2. = Moderate - something that is easily noted 3. = 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.
Safety and Adverse Event Profile	42 days