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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
428
Twice daily application for 7 days
Twice daily application for 7 days
Twice daily application for 7 days
Therapeutic Cure
Patients with clinical cure and mycologic cure are considered therapeutic cures.
Time frame: 42 Days
Clinical Cure
Patient will be considered a "clincal cure" if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2.
Time frame: 42 days
Mycologic Cure
Patient will be considered a "mycological cure" if the results of both the potassium hydroxide (KOH) and the fungal culture are negative.
Time frame: 42 Days
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Twice daily application for 7 days
Twice daily application for 7 days