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
February 2011 | Volume 10 | Issue 2 | Original Article | 165 | Copyright © February 2011
C. William Hanke MD,a Neil Swanson MD,b Suzanne Bruce MD,c
Brian Berman MD PhD,d James Kulp BS,e Sharon Levy MDe
aLaser and Skin Surgery Center, Carmel, IN
bDepartment of Dermatology, Oregon Health and Science University,
cCenter for Skin Research, Houston, TX
d Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, FL
e Product Development, Graceway Pharmaceuticals, LLC, Exton, PA
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.
J Drugs Dermatol. 2011;10(2):165-170.