Overview

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

Status:
Completed

Trial end date:
2012-12-01

Target enrollment:

Participant gender:

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).

Phase:

Phase 1

Details

Lead Sponsor:

Taro Pharmaceuticals USA

Treatments:

Butenafine
Clotrimazole
Miconazole