CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 462 enrolled
Drug / intervention
imiquimod +2 moredrug
Likely dose
imiquimod 0.25 gfrom 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.

Search/NCT00948428
NCT00948428Phase 3Completed
CompareCT.gov

A Multicenter, Double-Blind, Randomized, Parallel Group, Vehicle-Controlled Study to Determine the Clinical Equivalence of a Generic Imiquimod Cream, 5% and Aldara™ Cream in Subjects With Actinic Keratosis

Actavis Inc.·interventional·Posted Jul 29, 2009·Updated Sep 4, 2020

In Brief

A Phase 3 clinical trial evaluating imiquimod, Aldara™, and 1 other intervention for Actinic Keratoses. Completed, enrolled 462 participants across 20 sites.

Detailed Summary

At the end of the study, safety and efficacy outcome measures will be compared to determine a) if dosing with Generic Imiquimod cream, 5% is therapeutically equivalent to the currently marketed Aldara (imiquimod) cream, 5% and b) if both imiquimod 5% creams are superior in comparison to the Vehicle cream.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2009
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.9 years ago

Interventions

imiquimoddrug

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Aldara™drug

5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks

Vehicle Creamdrug

Topical cream vehicle matching Generic imiquimod dispensed in individual 0.25 g sachets applied twice a week for 16 weeks