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

 1. Male or non-pregnant, non lactating females 18 years of age or older.

 2. Signed informed consent form, which meets all criteria of current FDA regulations and
 the requirements of the India regulatory authorities.

 3. If female and of child bearing potential, have a negative urine pregnancy test at the
 baseline visit,

 4. 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

 5. A confirmed clinical diagnosis of interdigital tinea pedis.

 6. 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).

 7. 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:

 1. 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.

 2. Any known hypersensitivity to butenafine or other antifungal agents.

 3. 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.

 4. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who
 have been unresponsive to previous antifungal therapy.