Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis

Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Timeline

Start

2003-12

Primary completion

2004-05

Completion

2004-05

Drugs

Indications