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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

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ClinicalTrials.gov Identifier: NCT00189267
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 22, 2010
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Imiquimod 5 % Cream Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
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.
Study Start Date : November 2002
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.


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

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

ClinicalTrials.gov Identifier: NCT00189267     History of Changes
Other Study ID Numbers: 1443-IMIQ
First Posted: September 19, 2005    Key Record Dates
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