The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
707
Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days
Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.
Butenafine Vehicle applied twice daily for 7 consecutive days.
Therapeutic Cure
Subjects with both clinical cure and mycologic cure are considered therapeutic cures.
Time frame: 42 days
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