At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 561 enrolled
Drug / intervention
Ciclopirox Olamine Cream +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 Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
In Brief
A Phase 3 clinical trial evaluating Ciclopirox Olamine Cream, Loprox Cream 0.77%, and 1 other intervention for Tinea Pedis. Completed, enrolled 561 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2003
Primary CompletionMay 2004
First PostedDec 2008
TodayJul 2026
First PostedDec 5, 2008
Enrollment StartDec 1, 2003
Primary CompletionMay 1, 2004
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.6 years ago
Interventions
Ciclopirox Olamine Creamdrug
topical cream
Loprox Cream 0.77%drug
topical cream
Placebodrug
topical cream