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February 2011
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165
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VOLUME 10 • ISSUE 2
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Copyright © 2011
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Original Article
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Journal of Drugs in Dermatology
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Complete Clearance Is Sustained for at Least 12Months After Treatment of Actinic Keratoses ofthe Face or Balding Scalp Via Daily Dosing WithImiquimod 3.75% or 2.5% Cream
C. William Hanke MD, Neil Swanson MD, Suzanne Bruce MD, Brian Berman MD PhD, James Kulp BS, Sharon Levy MD
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.
J Drugs Dermatol. 2011;10(2):165-170.