NCT01580878

Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 707 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the comparability of the safety and efficacy of a generic Butenafine Hydrochloride Cream, 1% (test product) and Lotrimin Ultra® (the reference listed drug) in subjects with interdigital tinea pedis. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the vehicle cream (placebo).

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Butenafine Hydrochloride Cream, 1%	Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days
DRUG	Lotrimin Ultra®	Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.
DRUG	Butenafine Vehicle	Butenafine Vehicle applied twice daily for 7 consecutive days.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2012-04-19
• Last updated: 2017-05-05