NCT01119742

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

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Generic Butenafine Hydrochloride 1% Creams to Lotrimin Ultra® Cream in Patients With Interdigital Tinea Pedis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 428 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 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

• Interdigital Tinea Pedis

Interventions

Type	Name	Description
DRUG	Butenafine Hydrochloride 1%	Twice daily application for 7 days
DRUG	Butenafine Hydrochloride 1% B	Twice daily application for 7 days
DRUG	Butenafine Hydrochloride 1%	Twice daily application for 7 days
DRUG	Vehicle A	Twice daily application for 7 days
DRUG	Vehicle B	Twice daily application for 7 days

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-03-01
• Completion: 2011-07-01
• First posted: 2010-05-10
• Last updated: 2014-05-06