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A Study to Evaluate the Effec...

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

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Imiquimod 5 % Cream

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers