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
Phase 2
Completed
- Conditions
- Actinic Keratosis
- Registration Number
- NCT00189267
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
- Secondary Outcome Measures
Name Time Method Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.