NCT00802672

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

A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: Padagis LLC · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Ciclopirox Olamine Cream	topical cream
DRUG	Loprox Cream 0.77%	topical cream
DRUG	Placebo	topical cream

Timeline

• Start date: 2003-12-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2008-12-05
• Last updated: 2021-10-13
• Results posted: 2012-06-19