Evaluation of a new medical device shielding the skin of XP patients from UV-light

Xeroderma pigmentosum (XP) is a rare recessive hereditary syndrome characterized by extreme sensitivity to ultraviolet (UV) rays, with the appearance of various lesions on exposed skin and a very high risk of developing skin tumours, even in young people. To date, the prevention of exposure to UV rays is the only useful tool available to reduce the multiple and disfiguring surgical removal of cancerous lesions. This condition drastically affects the lifestyle and social relationships of XP patients, that are forced to live in shielded rooms, stay outside only at night, or wear special anti-UV clothing, gloves, glasses and bulky devices such as face shields during daytime. Cosmetic products on the market with a maximum protection factor (SPF50+) guarantee complete protection only for a limited time (about 60-120 minutes). In addition, their effectiveness is attenuated by sweat, water and gentle rubbing.

A new prototype has been produced in the laboratory. It consists of a gel matrix that polymerizes on the skin, generating an elastic film, resistant to mechanical friction, breathable, adhesive but not tacky, easy to apply and peel off, and above all it is capable of shield UV rays for long time and is not weakened by water.

The project aims to implement the prototype by assessing efficacy, safety and quality through in vitro tests on cells and artificial human skin, to comply the Medical Device Regulation 2017/ 745 (EU).