At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 247 enrolled
Drug / intervention
imiquimod cream +1 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.
A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses
In Brief
A Phase 3 clinical trial evaluating imiquimod cream and placebo cream for Actinic Keratosis. Completed, enrolled 247 participants across 18 sites in 2 countries.
Detailed Summary
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2009
First PostedMay 2009
Primary CompletionFeb 2010
TodayJul 2026
First PostedMay 7, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.2 years ago
Interventions
imiquimod creamdrug
Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period
placebo creamdrug
cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period