SPOT-IT
Research type
Research Study
Full title
SPOT-IT: cutaneous SCC Prevention using tOpical Therapy in Immunosuppressed patienTs
IRAS ID
1008229
Contact name
Margherita Carucci
Contact email
Sponsor organisation
Cardiff University
Research summary
Cutaneous squamous cell carcinoma (cSCC) is one of the commonest skin cancers with numbers increasing by 5% every year in the UK. Immunocompromised people have a much higher risk of developing cSCC and some will develop many cSCC requiring multiple surgical operations that can be cosmetically disfiguring, as they affect face or head. cSCC prevention is, therefore, especially important for people with a weakened immune system such as those who have received organ transplants who have the highest risk for new cSCC. Although we understand that some cSCC may develop from areas of sun-damaged skin called actinic keratoses (AK), there has been little research into how to prevent cSCC developing. AK occur on visible skin that has been regularly exposed to sunlight, including the face, ears, scalp, neck, and upper limbs. There are several treatments available for AK, such as sunscreen (applied daily) and the most effective 5-Fluorouracil 5% cream (5FU - applied twice a day for 4 weeks). Treating AK with 5FU cream, a form of topical chemotherapy, will reduce the chance of cSCC developing by 75% over the next year, though this treatment is difficult to tolerate as it causes red skin with pain, weeping/crusting and a distressing appearance that may last up to 6 weeks. Sunscreen has never been compared directly with 5FU. Recently, it was shown that combining 5FU with a vitamin D ointment called calcipotriol (5FU+CAL) boosts the effectiveness of 5FU such that only a 4 to 6-day treatment course is needed with side effects such as redness/crusting settling within 2 weeks. The purpose of the study is to compare which topical treatment (sunscreen, 5FU cream, or 5FU+CAL) is more effective in preventing cSCC.
If this study shows that 5FU and/or 5FU+CAL are effective at preventing development of new cSCC in immunocompromised people, this strategy is likely to become the new standard of care for these NHS patients. It would bring substantial patient benefits and reduce NHS costs.REC name
North West - Haydock Research Ethics Committee
REC reference
25/NW/0207
Date of REC Opinion
5 Sep 2025
REC opinion
Further Information Favourable Opinion