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Brief Title: Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
Official Title: Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations
Study ID: NCT01532453
Brief Summary: The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.
Detailed Description: This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care. The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische Universität Wien, Wien, , Austria
Charles University Hospital, Plzen, , Czech Republic
Hôpital Edouard, Lyon, , France
Klinikum der Charité Universitätsmedizin, Berlin, , Germany
Hautklinik am Nationalen Zentrum für Tumorerkrankungen, Heidelberg, , Germany
Beaumont Hospital, Dublin, , Ireland
Leiden University Medical Center, Leiden, , Netherlands
Universitätsspital Zürich, Dermatologische Klinik, Zürich, , Switzerland
Başkent University Faculty of Medicine, Ankara, , Turkey
Queen Mary University of London, London, , United Kingdom
Name: Claas Ulrich, MD
Affiliation: Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany
Role: PRINCIPAL_INVESTIGATOR