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.
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189267
First received: September 12, 2005
Last updated: November 19, 2010
Last verified: August 2006
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189267

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

No publications provided

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:
Aldara
Actinic Keratosis
Graft Recipients

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on September 18, 2014