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Brief Title: Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients
Official Title: Topical Imiquimod 5% Cream Therapy Versus Photodynamic Therapy With Methyl-aminolaevulinate 16% Cream of Actinic Keratoses in Organ Transplant Recipients
Study ID: NCT01538901
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical University of Vienna, University Clinic of Dermatology, Vienna, , Austria
Medical University of Vienna, Vienna, , Austria
Name: Stanislava Tzaneva, Doz. Dr.
Affiliation: Medical University of Vienna, University Clinic of Dermatology, Division of General Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Alexandra Geusau, Prof. Dr.
Affiliation: Medical University of Vienna, Division of Immunology, Allergy and Infectious Diseases
Role: PRINCIPAL_INVESTIGATOR