At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 467 enrolled
Drug / intervention
Imiquimod +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 Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of Generic Imiquimod Cream, 2.5% and Zyclara® (Imiquimod) Cream, 2.5% in Subjects With Actinic Keratoses
In Brief
A Phase 3 clinical trial evaluating Imiquimod, Zyclara®, and 1 other intervention for Actinic Keratosis. Completed, enrolled 467 participants across 27 sites.
Detailed Summary
The purpose of this study it so compare the safety and efficacy profiles of a generic imiquimod 2.5% cream to the reference listed Zyclara® (imiquimod) cream in the treatment of actinic keratosis (AK).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedApr 2014
Primary CompletionApr 2014
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartOct 10, 2013
Primary CompletionApr 30, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.2 years ago
Interventions
Imiquimoddrug
Cream, generic formulation of the brand product.
Zyclara®drug
Cream, brand product.
Vehicle Creamdrug
Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.