Vehicle-controlled, randomized, double-blind study to assess safety and efficacy of imiquimod 5% cream applied once daily 3 days per week in one or two courses of treatment of actinic keratoses on the head

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Abstract
Background Imiquimod has been investigated as a safe and effective therapeutic option for the treatment of actinic keratosis (AK). Objectives To evaluate imiquimod vs. vehicle applied three times a week for 4 weeks in one or two courses of treatment for AK on the face or balding scalp. Patients and methods Patients diagnosed with AK were enrolled in this multicentre, vehicle‐controlled, double‐blind study conducted in Europe. Twenty study centres enrolled a total of 259 patients in this study. Patients applied the study drug for 4 weeks, entered a 4‐week rest period and if they did not have complete clearance, they then entered a second course of treatment. Results Patients in the imiquimod group had an overall complete clearance rate of 55·0% (71/129) vs. a rate of 2·3% (3/130) for the vehicle group. There was a high rate of agreement between the clinical assessment and histological findings with respect to AK lesion clearance. At both 8‐week post‐treatment visits, the negative predictive value of the investigator assessment was 92·2% for clinical assessments vs. histological results. Conclusions A 4‐week course of treatment with three times weekly dosing of imiquimod 5% cream, with a repeated course of treatment for those patients who fail to clear after the first course of treatment, is a safe and effective treatment for AK. The overall complete clearance rate (complete clearance after either course 1 or course 2) is comparable to the 16‐week treatment regimen, while decreasing drug exposure to the patient and decreasing the overall treatment time.