At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 587 enrolled
Drug / intervention
Pimecrolimus Cream 1% (Valeant) +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.
Double-Blind Randomized Vehicle Controlled Study Evaluating Safety and Bioequivalence of Generic Pimecrolimus Cream 1% and Elidel® Comparing Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis
In Brief
A Phase 3 clinical trial evaluating Pimecrolimus Cream 1% (Valeant), Vehicle cream, and 1 other intervention for Atopic Dermatitis. Completed, enrolled 587 participants across 53 sites.
Detailed Summary
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedJun 2016
Primary CompletionJul 2016
TodayJul 2026
First PostedJun 6, 2016
Enrollment StartFeb 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.1 years ago
Interventions
Pimecrolimus Cream 1% (Valeant)drug
Vehicle creamdrug
Pimecrolimus Cream, 1%drug