RecruitingPhase IIIInterventional

SPOT-IT: prevention of the cutaneous squamous cell carcinoma in immunosuppressed patients using topical treatment

The SPOT-IT study is investigating new ways to prevent a common skin cancer called cutaneous squamous cell carcinoma (SCC) in people with weakened immune systems, such as organ transplant recipients. These individuals are at a much higher risk of developing SCC, which can be disfiguring and require multiple operations. Researchers are comparing different cream treatments. One existing treatment, 5-fluorouracil (5FU) cream, is effective but can cause uncomfortable side effects. A newer combination treatment, 5FU with a vitamin D ointment called calcipotriol (5FU+CAL), has shown promise in reducing these side effects while still being effective. This study will see if these creams, used annually for three years, are better at preventing SCC than just using daily sunscreen and regular check-ups. The goal is to find more effective and easier-to-tolerate ways to protect people from this skin cancer.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Cardiff University

Enrolment target

673

Start

01 Feb 2026

Estimated completion

31 Jan 2030

Cutaneous Squamous cell carcinoma (SCC) is a type of skin cancer. Some SCC may develop from areas of sun-damaged skin called actinic keratoses (AK), which arise on skin areas exposed to sunlight.

What is this study about?

This study, called SPOT-IT, is focused on helping people with weakened immune systems, like those who have had organ transplants, who are at a much higher risk of developing a type of skin cancer called cutaneous squamous cell carcinoma (SCC). This cancer often appears on areas of skin that have been exposed to a lot of sun, and sometimes develops from sun-damaged patches called actinic keratoses (AK). For people with weakened immune systems, SCC can be a significant problem, often requiring many operations that can change how they look, especially if the cancers are on the face or head. Because of this, finding good ways to prevent SCC is really important for them.

Currently, the advice for people who have had SCC is to use daily sunscreen. We also know that treating those sun-damaged patches (AK) can help prevent SCC. One effective treatment for AK is a cream called 5-fluorouracil (5FU), which helps remove the damaged skin cells. However, this cream can cause uncomfortable side effects like redness and soreness that can last for several weeks. Recently, doctors have been exploring a new approach, combining 5FU with a vitamin D ointment called calcipotriol (5FU+CAL). Early signs suggest this combination may work faster and cause fewer side effects, making it much easier to use.

The main aim of the SPOT-IT study is to understand if these cream treatments are better than just using sunscreen and having regular check-ups in preventing new SCCs. The study will compare 5FU cream alone, the 5FU+CAL combination cream, and the standard advice of daily sunscreen with monitoring. Participants will use their assigned cream each year for three years, and the researchers will track how many new SCCs develop over time. They will also collect information on side effects, pain, and how the treatments affect people's daily lives, to find the most effective and tolerable way to prevent this skin cancer for those at highest risk.

Key takeaways

The study aims to prevent a type of skin cancer (SCC) in people with weakened immune systems.
It tests if special creams are better than sunscreen at preventing SCC.
One cream is 5FU; another is a combination of 5FU and calcipotriol.
The study looks for treatments that are both effective and easier to tolerate.
Participation involves using a cream annually for three years and regular check-ups.
It could help improve care for future patients at high risk of SCC.

Who may be eligible?

This study is looking for adults aged 18 years and older who have a weakened immune system for various reasons, such as having received an organ or stem cell transplant, needing long-term medication for an immune condition, or living with HIV.

To be eligible, you must have had at least one SCC skin cancer in the past five years. If you've had an organ transplant, your new organ and your immune-suppressing medications need to have been stable for a certain period before joining the study.

You cannot join if you've previously had a bad reaction to the creams being tested (5FU or calcipotriol), have certain calcium problems, severe kidney or liver issues, or a specific genetic condition called DPD deficiency. Also, if you've recently used certain other skin treatments or are currently involved in another clinical study with new medicines, you wouldn't be able to participate. Pregnant, breastfeeding, or planning to conceive soon would also exclude you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have a weakened immune system (e.g., organ transplant, long-term immune medication, HIV)?
Have you had at least one SCC skin cancer in the last 5 years?
Are you able and willing to follow study instructions?
Are you NOT pregnant or breastfeeding, and not planning to conceive soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the study, you'll be advised to apply sunscreen daily, just like everyone in the study. You will also use a specific cream treatment (either 5FU alone or the 5FU+CAL combination) on certain areas of your skin. This cream application will be repeated once a year for three years. The study team will monitor your skin regularly during this time. After the three years of treatment, you'll continue to be followed for up to an additional four years to see how effective the treatment has been over the longer term.

Throughout the study, the team will ask you about any side effects you experience, such as redness or pain, and how the treatments affect your daily life and overall well-being. This will help them understand how well people tolerate the different treatments. The total time you would be involved in the study, including treatment and follow-up, could be up to seven years.

Potential risks and benefits

Taking part in this study might offer a chance to prevent new skin cancers or slow down the development of sun-damaged patches, though there's no guarantee the treatments will work for you. The information gathered will be very valuable for doctors trying to find better ways to help future patients with similar skin conditions. As with all medications, the creams used in this study can cause side effects, such as skin redness and discomfort, but these are usually manageable with support from the study team. All side effects are carefully monitored by the research team and an independent group to ensure your safety. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Cardiff University
Approximate
Cardiff, Wales

Common questions

What is SCC?

SCC stands for squamous cell carcinoma, which is a common type of skin cancer that often appears on sun-exposed skin.

Why are people with weakened immune systems at higher risk?

Having a weakened immune system makes it harder for your body to fight off cancer cells, increasing your risk of developing SCC significantly.

What is 5FU cream?

5FU is a cream treatment that helps remove abnormal, sun-damaged skin cells that could turn into skin cancer.

What are the main treatments being tested?

The study is testing 5FU cream alone, a combination of 5FU and calcipotriol cream, and comparing them to daily sunscreen use with regular check-ups.

How long will I be in the study?

You would be treated with creams for three years, with a follow-up period that could last up to an additional four years, for a total of up to seven years.

How to find out more

Study contact -

SPOT-IT@cardiff.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.