Trial Information

A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Four Weeks of Treatment With Imiquimod Creams for Actinic Keratoses

This was a randomized, double-blind, multicenter, placebo-controlled study that compared the
efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo
in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects
were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits).
Subjects determined to be eligible during the screening phase were randomized in a 1:1:1
ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were
applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of
daily treatment followed by 2 weeks of no treatment, and the second treatment cycle
consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
The investigator selected the treatment area for the study (either the entire face or the
entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment
area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular
areas, lips, and nares. Study medication was applied prior to normal sleeping hours and
removed approximately 8 hours later with mild soap and water. Ears were excluded from both
assessment and treatment. Rest periods from daily treatment were instituted by the
investigator as needed to manage local skin reactions (LSRs) or application site reactions,
with resumption of treatment upon adequate resolution as determined by the investigator.

The duration of each subject's study participation was approximately 18 weeks, including a
4-week maximum screening period and a 14-week study period.