CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 425 enrolled
Drug / intervention
Imiquimod 5% manufactured by Taro +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.

Search/NCT00828568
NCT00828568Phase 1Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Two Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

Sun Pharmaceutical Industries, Inc.·interventional·Posted Jan 26, 2009·Updated Jan 28, 2014

In Brief

A Phase 1 clinical trial evaluating Imiquimod 5% manufactured by Taro, Aldara - Imiquimod 5%, and 1 other intervention for Actinic Keratosis. Completed, enrolled 425 participants across 20 sites.

Detailed Summary

The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.

Study Details

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

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 26, 2009
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.4 years ago

Interventions

Imiquimod 5% manufactured by Tarodrug

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Aldara - Imiquimod 5%drug

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Imiquimod Vehicle manufactured by Tarodrug

Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks