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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:
ClinicalTrials.gov Identifier:
NCT00189267
First Posted: September 19, 2005
Last Update Posted: November 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MEDA Pharma GmbH & Co. KG
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189267


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

ClinicalTrials.gov Identifier: NCT00189267     History of Changes
Other Study ID Numbers: 1443-IMIQ
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: November 22, 2010
Last Verified: August 2006

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
Antineoplastic Agents
Interferon Inducers