At a glance
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A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
In Brief
A Phase 1 clinical trial evaluating Butenafine cream 1% manufactured by Taro, Lotrimin Ultra (butenafine) 1%, and 1 other intervention for Tinea Pedis. Completed, enrolled 548 participants across 17 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
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