Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Completed
Taro Pharmaceuticals USA
Phase 1
2008-06-01
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).
Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis
Terminated
Taro Pharmaceuticals USA
Phase 1
2010-07-01
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).
Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis
Completed
Taro Pharmaceuticals USA
Phase 1
2012-01-01
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).
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