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

This study has been completed.
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: November 19, 2010
Last verified: August 2006
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.

Condition Intervention Phase
Actinic Keratosis
Drug: Imiquimod 5 % Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • 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:
  • Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.

Estimated Enrollment: 45
Study Start Date: November 2002
Study Completion Date: September 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189267

Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Study Chair: Study Coordinator Universitaetsklinikum Charite
  More Information

ClinicalTrials.gov Identifier: NCT00189267     History of Changes
Other Study ID Numbers: 1443-IMIQ 
Study First Received: September 12, 2005
Last Updated: November 19, 2010
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Dutch Health Care Inspectorate

Keywords provided by MEDA Pharma GmbH & Co. KG:
Actinic Keratosis
Graft Recipients

Additional relevant MeSH terms:
Keratosis, Actinic
Precancerous Conditions
Skin Diseases
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016