Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
|Actinic Keratoses Squamous Cell Carcinomas||Device: MD-3511356 Other: Standard Sun Protection Measures||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- 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 ]
|Study Start Date:||November 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Standard Sun Protection Measures
Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).
Other: Standard Sun Protection Measures
Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).
Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532453
|Medizinische Universität Wien|
|Charles University Hospital|
|Plzen, Czech Republic|
|Klinikum der Charité Universitätsmedizin|
|Berlin, Germany, 10117|
|Hautklinik am Nationalen Zentrum für Tumorerkrankungen|
|Leiden University Medical Center|
|Universitätsspital Zürich, Dermatologische Klinik|
|Başkent University Faculty of Medicine|
|Queen Mary University of London|
|London, United Kingdom|
|Principal Investigator:||Claas Ulrich, MD||Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany|