Multicentre, open-label study using imiquimod 5% cream in one or two 4-week courses of treatment for multiple actinic keratoses on the head.

OBJECTIVE

In the USA, Imiquimod 5% cream is approved for use 2-3 times per week over 16 weeks for the treatment of actinic keratoses (AKs). This study evaluated the efficacy of imiquimod in another treatment schedule, for AKs on the head.

DESIGN

Open-label, phase IIIb.

SETTING

180 dermatology clinics and practices in Germany.

PATIENTS: Patients were eligible if they had clinically typical, visible AK lesions located anywhere on the head, excluding the upper and lower eyelids, nostrils, lip vermilion, and inside the ears.

INTERVENTIONS: Patients applied study cream to the treatment area once daily 3x/week for 4 weeks (course 1) followed by a 4-week post-treatment period. Patients with AK lesions remaining in the treatment area underwent a second 4-week treatment course.

MAIN OUTCOME MEASURES: Primary variable was the complete clearance rate, defined as the proportion of patients with no clinically visible AK lesions in the treatment area at the course 1 or course 2 post-treatment visit.

RESULTS

829 patients entered the study. Overall, the complete clearance rate was 68.9% (571/829) and the partial clearance rate (percentage of patients with >/= 75% reduction in the number of baseline AK lesions) was 80.2%. Local skin reactions (LSRs) and application site reactions (ASRs) were the most commonly reported adverse events. Four patients discontinued from the study due to LSRs or ASRs.

CONCLUSIONS

Shorter treatment regimen of imiquimod 5% cream can produce complete clearance rates similar to those seen with 16 weeks of treatment and has the advantage of lower drug exposure, resulting in a better benefit-risk profile for the patient.