Q&A

Is imiquimod effective and safe for treatment of actinic keratosis?

J Fam Pract. 2003 March;52(3):183-200
By
Kendall J. Walker, MD
Clint Koenig, MD, MSPH
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  • BACKGROUND: Actinic keratosis is a precancerous skin lesion commonly found on areas frequently exposed to the sun. Among aging Americans, these lesions are regularly identified and treated in the clinical setting with cryotherapy. This manufacturer-sponsored study evaluated the efficacy and safety of 5% imiquimod (Aldara) cream for the treatment of actinic keratosis.
  • POPULATION STUDIED: Patients were selected from a dermatology practice in Germany. Of 52 patients screened, 36 men and women with histopathologically diagnosed actinic keratosis were enrolled. Study patients were ages 45 to 85 years. Each patient had 3 to 10 actinic keratosis lesions on the scalp, forehead, dorsal forearm, neck, or dorsal hand.
  • STUDY DESIGN AND VALIDITY: The study was a randomized, double-blind, vehicle-controlled clinical trial. Histopathologic diagnosis was confirmed in 36 enrollees. The imiquimod group had 25 patients, while the vehicle cream control group had 11 patients. Masking of patients, physicians, and outcome assessors was appropriate, as was allocation concealment.
  • OUTCOMES MEASURED: The number and appearance of lesions were evaluated during and after treatment. Clinical clearance was confirmed by histopathology. All adverse reactions were recorded.
  • RESULTS: Twenty-one participants (84%) of the treatment group experienced complete clinical and histological clearance; 2 additional participants (8%) had partial clearance. Among the 11 control group patients, there was no reduction in the size or number of lesions.
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PRACTICE RECOMMENDATIONS:

Imiquimod 5% cream, applied 3 times per week for 12 weeks, is effective for treatment of actinic keratosis. Severe erythema and other local reactions occurred in almost everyone receiving treatment, due to imiquimod’s immune system– modulating effects.

The 25 patients in the treatment group tolerated these adverse effects well. Despite these effects, imiquimod can be used as an alternative to traditional cryotherapy for the treatment of actinic keratosis among selected, motivated patients.

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