 This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 12.5 mg to 6 packets 75 mg to either single or multiple body regions for up to 3 cycles, depending upon treatment success and AK lesion recurrence. Eligible subjects applied imiquimod 5 cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. Multiple treatment areas could be exposed i.e., head, torso andor extremities, with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. In each treatment cycle, dosing was to continue for 16 weeks approximately 4 months, as instructed by the investigator, followed by a 2-month, treatment-free follow-up period. 