Extrait

Background and study aims Sunshine has both positive and negative effects on health. Humans require sunlight to manufacture vitamin D in the skin however too much sun exposure can cause DNA damage, photo aging and skin cancer. Products of DNA damage repair are excreted in urine making them potentially useful indicators of sunlight exposure and hence risk of skin cancer. This study aims to validate DNA damage in urine as a marker of ultraviolet rays (UVR)-induced skin DNA damage. We will also assess the applicability of urinary DNA damage to assessment of the risk (DNA damage) versus benefit (vitamin D production) of UVR exposure. Who can participate? This study will involve healthy male and female adults of all skin types, aged 18-45 years from Greater Manchester. What does the study involve? Subjects will first have their sunburn threshold determined then will receive a single, whole body (exposing 35% skin surface area) exposure below this threshold, mimicking a short exposure to sunlight on a summer’s day. Subjects will then collect their urine for five days which will be tested for products of DNA damage. In the second part of the study, subjects will receive four increasing doses of UVR (all below their sunburn threshold), separated by 1 month. Urine and skin biopsy samples will be taken before and after exposure to examine for DNA damage. In addition, blood samples will be taken before and after exposure for vitamin D analysis. What are the possible benefits and risks of participating? This study will not provide direct benefit to research participants. However, if any participant taking part is found to have vitamin D levels defined as deficient, their GP will be notified in order that appropriate treatment/advice may be given. Following UVR exposure for sunburn threshold testing, transient redness will be experienced on the exposed area. Tanning of the skin may occur in areas where UVR has been applied. Slight discomfort or bruising may be experienced during blood sampling but this is minimised by using experienced venepuncture practitioners. Skin biopsies on the buttocks may result in small permanent scars. Where is the study run from? Photobiology Unit, Salford Royal NHS Foundation Trust. When is the study starting and how long is it expected to run for? This study will run from June 2012 for 30 months. Who is funding the study? Cancer Research UK Who is the main contact? Jessica Edwards, Research Associate [email protected]

Critère d'inclusion

• Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology

Liens

• isrctn
• ictrp