Open-Label Study to Assess Safety and Efficacy of Imiquimod 5% Cream Applied 3 Days Per Week in 1 or 2 Cycles for Treatment of Actinic Keratoses on the Head
This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic
keratoses on the head to reduce the size of lesions. The objective is to analyze the effect
of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is
applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is
defined as the proportion of subjects with no clinically visible AK lesions in the treatment
area at the end of cycle 1 or the end of cycle 2.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete clearance rate - defined as the proportion of subjects at the end of cycle 1 or cycle 2 with no (zero) clinically visible AK lesions in the treatment area.
Jason K Rivers, M.D.
Division of Dermatology, University of British Columbia
Canada: Health Canada