Overview

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

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Treatments:
Imiquimod
Criteria
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