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.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis
Both
Actinic Keratosis
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
Principal Investigator
Study Coordinator
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaetsklinikum Charite
Authority:
United States: Food and Drug Administration
Study ID:
1443-IMIQ
NCT ID:
NCT00189267
Start Date:
November 2002
Completion Date:
September 2005
Related Keywords:
- Actinic Keratosis
- Aldara
- Actinic Keratosis
- Graft Recipients
- Keratosis
- Keratosis, Actinic
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