Trial Information

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

These were a randomized, double-blind, multicenter, placebo-controlled studies 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 AK of the face or balding scalp.
Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 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 3 weeks
of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle
consisted of an additional 3 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 21 weeks, including a
4-week maximum screening period and a 17-week study period. At the End of Study (EOS)
visit, eligible subjects may have been invited to participate in a separate study evaluating
AK recurrence.