NCT01538901

Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients

Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two different therapies for actinic keratoses in organ transplant recipients with regard to efficacy and tolerability. The investiagtors are planning to examine treatment with Imiquimod 5% cream versus treatment with Methyl-aminolaevulinate 16% cream and subsequent irradiation with red light, so-called photodynamic therapy, in this patients' group. A secondary objective of our study is to investigate the reduction in the field cancerisation after both treatments using fluorescence diagnostic method and digital imaging.

Detailed description

Organ transplant patients (OTP) require lifelong immunosuppressive therapy and consequently are prone to develop skin tumors, i.e skin cancer is the most frequent malignancy in organ transplant recipients. OTP frequently develop extensive areas of actinic damage, epidermal dysplasia, wich accounts for increased risk of aggressive skin cancer development in susceptible patients, and are referred to as "field cancerisation". Therefore the whole area of field cancerisation has to be treated. In our study we will treat this areas with two different methods and not only the single visible lesions of actinic keratoses.In this open prospective randomized intraindividual study one half of the patients' scalp or face will be treated with Imiquimod 5% cream for 4 weeks, 3 times a week, and the other half with Methyl-aminolaevulinate 16% cream photodynamic therapy, two applications in two weeks interval. The pre- and post treatment extension of field cancerisation will be assessed by means of a highly sensitive digital fluorescence imaging system.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
OTHER	photodynamic therapy	Methyl-aminolaevulinate 16% cream (Metvix) will be applied on the treated area under occlusion for 3 hours. It follows irradiation with visible red light at a peak wavelength of 630 nm (Actilite CL128) with a single dose of 37 J/cm2.
DRUG	imiquimod 5% cream	250 mg imiquimod 5% cream will be applied over night for a total of 3 nights in the week, for duration of 4 weeks

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-02-24
• Last updated: 2017-09-12

Locations

2 sites across 1 country: Austria