A Study to Evaluate the Effectiveness and Safety of Multiple Applications of Imiquimod 5% Cream for the Treatment of Actinic Keratoses in Organ Transplant Recipients

Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream Applied Once Daily 3 Days Per Week for the Treatment of Actinic Keratoses in Immunosuppressed Organ Transplant Recipients.

The purpose of the study is to compare effectiveness and safety of multiple applications of imiquimod 5% cream and vehicle cream in graft recipients suffering from actinic keratosis.

Inclusion Criteria:

• Have a total of 4-10 actinic keratosis (AK) lesions located on either face or scalp
• If female and of childbearing potential, have a negative urine pregnancy test at treatment initiation, and willing to use a medically acceptable method of contraception during the treatment period
• Renal, liver or heart transplant recipients

Exclusion Criteria:

• Graft rejection with loss of the graft in the medical history
• Unstable status of organ transplant disease during the last 12 months
• Known to be pregnant or lactating