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NCT00189267 Clinical Trial

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

Actinic Keratosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189267
Other study ID # 1443-IMIQ
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2002
Est. completion date September 2005

Study information
Verified date August 2006
Source Viatris Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Imiquimod 5 % Cream

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
MEDA Pharma GmbH & Co. KG

Outcome
Type Measure Description Time frame Safety issue
Primary Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.
Secondary Secondary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to complete and partial clearance rates.
See also
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