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Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams as Compared to Lotrimin Ultra Cream in Patients With Interdigital Tinea Pedis

2014-07-24 14:05:48 | BioPortfolio

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Interdigital Tinea Pedis

Intervention

Butenafine Hydrochloride 1%, Butenafine Hydrochloride 1% B, Butenafine Hydrochloride 1%, Vehicle A, Vehicle B

Status

Not yet recruiting

Source

Taro Pharmaceuticals USA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:05:48-0400

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