Complete clearance is sustained for at least 12 months after treatment of actinic keratoses of the face or balding scalp via daily dosing with imiquimod 3.75% or 2.5% cream.

Objective: Assess long-term, sustained, complete clearance of actinic keratoses after treatment with imiquimod 3.75% or 2.5% cream using two two-week or three-week cycles of daily dosing.

Methods: Adults with five to 20 baseline actinic keratoses who achieved complete clearance at the eight-week post-treatment visit in four phase 3 placebo-controlled treatment studies were followed for an additional 12 months.

Results: For imiquimod 3.75% and 2.5% cream, respectively, complete clearance was sustained for 12 months in 17/42 (40.5%) and 13/39 (33.3%) subjects from the two-week cycle studies, and in 23/48 (47.9%) and 16/37 (43.2%) subjects from the three-week cycle studies. There were no safety concerns during the follow-up.

Conclusion: In subjects with a median of eight to nine baseline actinic keratoses who achieved complete clearance after treatment of the full face or balding scalp with topical imiquimod 3.75% cream, complete clearance of all lesions (baseline, recurrent or new) was sustained in ≥ 40 percent of subjects for at least 14 months after the last dose. Clinicaltrials.gov identifier NCT00668733.