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