NCT00835510

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 548 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Butenafine cream 1% manufactured by Taro	Treatment applied to affected area twice daily for 7 days
DRUG	Lotrimin Ultra (butenafine) 1%	Treatment applied to affected area twice daily for 7 days
DRUG	Butenafine Vehicle manufactured by Taro	Treatment applied to affected area twice daily for 7 days

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2009-02-03
• Last updated: 2014-02-04
• Results posted: 2009-10-06

Locations

17 sites across 2 countries: United States, Belize