CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 589 enrolled
Drug / intervention
Imiquimod Cream, 3.75% +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/NCT01686152
NCT01686152Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis of the Face or Balding Scalp

Teva Pharmaceuticals USA·interventional·Posted Sep 17, 2012·Updated Nov 24, 2020

In Brief

A Phase 3 clinical trial evaluating Imiquimod Cream, 3.75%, Zyclara®, and 1 other intervention for Actinic Keratosis. Completed, enrolled 589 participants across 23 sites.

Detailed Summary

To determine the comparability of the safety and efficacy of Imiquimod Cream, 3.75% and Zyclara (imiquimod) Cream, 3.75% (the reference listed drug) in subjects with actinic keratosis (AK) of the face or balding scalp. It will also be determined whether the efficacy of each of the two active treatments is superior to that of the Vehicle cream.

Study Details

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

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2012
Enrollment StartSep 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.8 years ago

Interventions

Imiquimod Cream, 3.75%drug

Zyclara®drug

Vehicle of Test Productother