Trial Information

Open-Label Safety and Pharmacokinetic Study of AldaraTM (Imiquimod) Cream, 5% for One, Two, or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis

This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects
aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational
sites in the United States.

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 and/or 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.