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

MEDA Pharma GmbH & Co. KG45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Actinic Keratosis

Interventions

Imiquimod 5 % CreamDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary outcome of the study is to compare imiquimod 5% cream and vehicle cream with respect to safety assessments in graft recipients.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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