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Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

Tinea Pedis Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00835510
Study type Interventional
Source Taro Pharmaceuticals USA
Contact
Status Completed
Phase Phase 1
Start date June 2008
Completion date December 2008
View Details
See also
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