Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Butenafine cream 1% manufactured by Taro; Lotrimin Ultra (butenafine) 1%; Butenafine Vehicle manufactured by Taro
Intervention description: Treatment applied to affected area twice daily for 7 days; Treatment applied to affected area twice daily for 7 days; Treatment applied to affected area twice daily for 7 days
Intervention MeSH terms: Butenafine; Clotrimazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Tinea pedis

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).
    

Eligibility criteria:

        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.