Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical complete response rate of actinic keratoses
The clinical complete response rate of actinic keratoses is defined as a proportion of the number of actinic keratoses with a clinically determined complete clearance(no visible and/or palpable actinic keratoses) to the number of the actinic keratoses at baseline.
4 weeks after end of treatment
Stanislava Tzaneva, Doz. Dr.
Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
Austria: Austrian Agency for Health and Food Safety (AGES)