At a glance
ClinicalIndex Comparison RecordN/ACompleted· 553 enrolled
Drug / intervention
Ciclopirox Olamine Topical Suspension +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Ciclopirox Olamine Topical Suspension, Ciclopirox Topical Suspension 0.77%-Reference Product, and 1 other intervention for Tinea Pedis. Completed, enrolled 553 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis
Countries--
Collaborators--
Timeline
N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
Primary CompletionDec 2004
Study CompletionApr 2005
First PostedDec 2008
TodayJul 2026
First PostedDec 8, 2008
Enrollment StartJun 1, 2004
Primary CompletionDec 1, 2004
Study CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.6 years ago
Interventions
Ciclopirox Olamine Topical Suspensiondrug
topical suspension
Ciclopirox Topical Suspension 0.77%-Reference Productdrug
topical suspension
Ciclopirox Olamine Topical Suspension-Placebodrug
topical suspension