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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
244
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
Medizinische Universität Wien
Vienna, Austria
Charles University Hospital
Pilsen, Czechia
Hôpital Edouard
Lyon, France
Klinikum der Charité Universitätsmedizin
Berlin, Germany
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
Time frame: 2 Years
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
Time frame: 2 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hautklinik am Nationalen Zentrum für Tumorerkrankungen
Heidelberg, Germany
Beaumont Hospital
Dublin, Ireland
Leiden University Medical Center
Leiden, Netherlands
Universitätsspital Zürich, Dermatologische Klinik
Zurich, Switzerland
Başkent University Faculty of Medicine
Ankara, Turkey (Türkiye)
Queen Mary University of London
London, United Kingdom