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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00835510

BTNF-0708

Details and patient eligibility

About

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).

Enrollment: 548 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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548 participants in 3 patient groups, including a placebo group

Butenafine cream 1% (Taro)

Experimental group

Description:

Butenafine cream manufactured by Taro applied for 7 days

Treatment:

Drug: Butenafine cream 1% manufactured by Taro

Lotrimin Ultra (butenafine) 1%

Active Comparator group

Description:

Lotrimin Ultra (butenafine) applied for 7 days

Treatment:

Drug: Lotrimin Ultra (butenafine) 1%

Vehicle

Placebo Comparator group

Description:

Butenafine vehicle applied for 7 days

Treatment:

Drug: Butenafine Vehicle manufactured by Taro