NCT00189267CompletedPhase 2
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- MEDA Pharma GmbH & Co. KG
- Enrollment
- 45
- Primary Endpoint
- Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
Secondary Outcomes
- Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.
Investigators
Similar Trials
Completed
Phase 4
Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic KeratosesKeratosisActinic KeratosisNCT00110682Derm Research @ 888 Inc.60
Completed
Phase 4
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and HandsKeratosisNCT00115154Graceway Pharmaceuticals, LLC270
Completed
Phase 2
A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the FaceSeborrheic Dermatitis on the FaceNCT00408330LEO Pharma48
Completed
Phase 3
A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic KeratosesActinic KeratosisNCT02120898Actavis Inc.467
Terminated
Phase 4
Intravenous (IV) Solutions for Dehydration in Children With GastroenteritisDehydrationGastroenteritisNCT01234883Baxter Healthcare Corporation100