Clinical efficacy and safety of sequential therapy with cryotherapy and topical tirbanibulin 1% in actinic keratoses in transplant recipients: a randomised clinical trial.
This research is investigating a common skin problem called actinic keratosis (AKs), especially in people who have had organ transplants. AKs are rough, scaly patches on the skin caused by too much sun exposure, and they can sometimes turn into a type of skin cancer if not treated. The study is comparing two ways of treating these spots: one involves freezing them off (cryotherapy) followed by applying a cream called Klisyri, and the other just uses freezing therapy. The main goal is to see if adding the Klisyri cream makes the treatment more effective at reducing or clearing these skin spots over three months. Researchers will also check how safe each treatment is and how it affects patients' quality of life.
At a glance
What is this study about?
This study is about a common skin condition called actinic keratosis (AKs). These are rough, scaly patches on the skin, often found on areas exposed to the sun, like the face, hands, or scalp. While AKs aren't skin cancer, they can sometimes develop into a type of skin cancer if left untreated, so it's important to keep an eye on them and treat them. This particular study is focusing on people who have had organ transplants, as they can be more prone to developing AKs.
The researchers want to find the best way to treat these spots. They are comparing two treatment approaches: one uses a common treatment called cryotherapy, which involves freezing off the spots. The other approach combines this cryotherapy with a special cream called Klisyri (its active ingredient is tirbanibulin 1%). By comparing these two methods, the study aims to understand if adding the Klisyri cream to cryotherapy helps clear the AKs more effectively than cryotherapy alone.
The main thing they'll be looking at is how much the number of AKs changes after three months with each treatment. They will also check if people achieve a complete clear-up of their spots or a significant reduction. Importantly, the study will also look at how patients tolerate the treatments, any side effects they might experience, and how the treatments affect their daily lives and overall satisfaction.
Key takeaways
- The study explores better treatments for sun-damaged skin spots (actinic keratosis).
- It focuses on transplant patients, who can be more vulnerable to these spots.
- It compares freezing therapy alone to freezing therapy combined with Klisyri cream.
- The main goal is to see which treatment clears more spots over three months.
- Researchers will also check for side effects and how treatments affect daily life.
Who may be eligible?
To join this study, generally, you need to be an adult, aged 18 or older. Both men and women can take part in this research.
Because the study focuses on actinic keratosis in transplant patients, it's likely that you would need to have received an organ transplant in the past and currently have these sun-damaged skin spots. The doctors running the study will check specific details about your health and your skin condition to make sure the study is right for you and that you meet all the necessary requirements.
This also means that if you haven't had an organ transplant, or if you don't have actinic keratosis, you probably wouldn't be able to join this particular study. The medical team will work through all the specific criteria with you during an initial check-up.
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 old or older?
- Have you had an organ transplant?
- Do you currently have actinic keratosis skin spots?
- Are you comfortable visiting a clinic for regular check-ups?
- Are you able to apply a topical cream if needed?
What does participation involve?
If you decide to take part in this study, you would likely have several visits to the clinic over a few months. During these visits, doctors would first assess your actinic keratosis spots to decide which ones will be part of the study. You'd then receive different treatments on different areas of your skin – for example, one side of your face might get freezing treatment plus the Klisyri cream, while another might get just freezing treatment.
You would be given instructions on how to apply the Klisyri cream at home, if that's part of your treatment. Throughout the study, the medical team will regularly check your skin to see how the spots are responding to treatment.
They will also ask you questions about how you’re feeling, any discomfort or side effects you might have, and how the treatment affects your daily life. This helps them understand the tolerance and overall impact of each treatment. You'll have follow-up appointments to track the progress of your skin over the three-month period. The total duration of your active involvement in the study will be at least three months, possibly with some follow-up beyond that.
Potential risks and benefits
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Common questions
What is actinic keratosis?
Actinic keratosis (AKs) are rough, scaly patches on your skin, typically caused by years of sun exposure. They are considered pre-cancerous, meaning they can sometimes turn into a type of skin cancer if not treated.
Why are transplant patients included in this study?
People who have had organ transplants often take medications that suppress their immune system, which can make them more likely to develop skin conditions like actinic keratosis.
What is Klisyri cream?
Klisyri is a medicine in a cream form that contains an active ingredient called tirbanibulin. It's used to treat actinic keratosis.
Will I know which treatment I'm getting?
The study aims to compare treatments. You might receive different treatments on different areas of your skin, and the medical team will explain what you are getting.
How long will I be in the study?
The main part of the study where your skin is closely monitored will last for at least three months, with likely follow-up appointments after that.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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