NCT00804193

Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 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 Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 553 (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 Topical Suspension (Test Product) and Ciclopirox Topical Suspension 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 Topical Suspension	topical suspension
DRUG	Ciclopirox Topical Suspension 0.77%-Reference Product	topical suspension
DRUG	Ciclopirox Olamine Topical Suspension-Placebo	topical suspension

Timeline

• Start date: 2004-06-01
• Primary completion: 2004-12-01
• Completion: 2005-04-01
• First posted: 2008-12-08
• Last updated: 2021-10-27
• Results posted: 2012-12-17