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

Meda Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Imiquimod 5 % Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189267

1443-IMIQ

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind