CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 490 enrolled
Drug / intervention
Imiquimod cream +2 moredrug
Likely dose
Imiquimod cream 250 mgfrom 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/NCT00603798
NCT00603798Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

Graceway Pharmaceuticals, LLC·interventional·Posted Jan 29, 2008·Updated Jun 29, 2010

In Brief

A Phase 3 clinical trial evaluating Imiquimod cream and Placebo cream for Actinic Keratosis. Completed, enrolled 490 participants across 26 sites.

Detailed Summary

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 29, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.4 years ago

Interventions

Imiquimod creamdrug

250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.

Placebo creamdrug

250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.

Imiquimod creamdrug

250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.