Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at imiquimod cream as treatment for an early type of skin cancer (LIMIT - 1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at using imiquimod cream to treat an early type of skin cancer called lentigo maligna.
Lentigo maligna is a dark patch of skin which grows slowly over many years. It occurs on areas of the skin that have seen a lot of sun exposure such as the face. It grows and spreads over the outer layer of the skin. If left untreated it may start to grow deep into the skin. It is then called lentigo maligna melanoma.
Doctors use surgery to remove lentigo maligna. But this can be stressful and unpleasant. It can also leave scarring which may be noticeable. Surgery may also cause nerve damage, which can affect normal movement and cause an eyelid to droop for example.
The researchers think that using imiquimod cream may be just as good as surgery to treat lentigo maligna. They want people to use the cream before surgery to see what effect it has.
The aims of this trial are to find out
- How well imiquimod cream works to treat people with lentigo maligna
- How well people tolerate using the cream
- If using imiquimod cream might protect people with lentigo maligna against getting melanoma
- What people think about using imiquimod cream
Who can enter
You can enter this trial if
- You have a lentigo maligna above the base of your neck
- Your lentigo maligna has been confirmed by a tissue sample (biopsy)
- Your lentigo maligna measures at least 10mm across and the border can easily be seen
- You are at least 45 years old
You cannot enter this trial if you
- Have lentigo maligna that has come back after treatment
- Have lentigo maligna that has started to grow deeper into your skin
- Have a melanoma skin cancer or a non melanoma skin cancer
- Are having treatment or taking a drug as part of another clinical trial
- Are taking medication that suppresses your
immune system– it is important that you do not stop taking your medication without talking to your doctor
- Are sensitive to imiquimod or to any of the ingredients in the cream
- Are pregnant or breastfeeding
This trial will recruit about 40 people from about 14 centres in the UK.
Everyone will use imiquimod cream before having surgery to remove their lentigo maligna.
Before starting to use the imiquimod cream the doctor will use non permanent ink and small pinpoint tattoos to mark out the size and shape of your lentigo maligna. They will record this on a map. They will also take a photograph of it and put both in your medical records. The doctors will use them to compare the size and shape of your lentigo maligna before and after treatment.
The researchers will take 2 blood samples. They will use these to see if the imiquimod cream triggers your immune system to work against the lentigo maligna.
You apply the imiquimod cream for about 12 weeks. The medical team will explain how to apply the cream and how often. After another 10 to 12 weeks the researchers take up to 3 small tissue samples (biopsies) of your lentigo maligna before you have surgery.
You have a diary to write down when you put the cream on and any reactions you may have. You answer a weekly question in your diary asking what you think about using the imiquimod cream. You also write down any extra visits to the doctor or nurse and any other dressings or creams you use if needed. You take the diary with you to every clinic visit.
About 12 weeks after surgery the research team will ask you to complete a questionnaire. It will ask how you felt about using the imiquimod cream.
You see the doctor regularly while using the imiquimod cream at 1, 2, 4, 8 and 12 weeks after starting your treatment. If you have any problems between these visits, you can telephone your doctor or nurse and they will arrange to see you if necessary.
Because imiquimod cream stimulates your immune system, the skin may become red, swollen, itchy or painful. You may also have flu like symptoms including aching, tiredness, shivering and fever. Your doctor will tell you to change the amount of cream you use to help control these side effects.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Jerry Marsden
NIHR Research for Patient Benefit (RfPB) Programme
NIHR Clinical Research Network: Cancer
University Hospital Birmingham NHS Foundation Trust