Why are we doing the Acne-ID study?
Athough many teenagers experience acne, around 1 in 10 of people get severe acne that can also scar the skin. Having acne on your face and body as a young person can affect your confidence, sometimes leading to low mood and anxiety. There is an effective treatment for severe acne called isotretinoin, which is a licenced drug. Although isotretinoin works well at clearing acne, most people who take it experience side-effects, and some people will experience these more than others.
What are the aims of the study?
One way we may be able to reduce these side effects is to give a lower dose of isotretinoin possibly over a longer period of time. We want to be sure a lower dose (possibly taken for longer) clears acne as well as the standard dose and find out if people are happy to take the tablets for a longer period of time. It is also possible that if acne is treated at a lower dose, it may come back after stopping treatment, so we also need to check that out.
We are looking for young people, aged 12-24, with severe acne, and have not previously been treated with isotretinoin. Patients will only be approached to join the trial once the joint decision between patient and doctor has been made to start isotretinoin.
What will the study be testing?
This study involves two groups of patients; one group will take the dose of isotretinoin usually prescribed (standard dose) and the other group will take a lower dose. Patients will not get to choose which group they are put into. This study will compare the advantages and disadvantages of two different doses of isotretinoin for people with severe acne.
What does the study involve?
At the start of the study, there will be time with the research team to make sure patients understand about the study and are consented to take part. Whilst on isotretinoin, patients in the study will keep attending their usual dermatology appointments for drug monitoring. Within some of the clinic appointments there will be a quick assessment of how severe the acne is.
Patients will receive electronic, or if preferred paper, questionnaires to ask about how bothersome side effects to isotretinoin are, if there have been any mood changes, quality of life, and satisfaction with treatment. After stopping isotretinoin patients will receive questionnaires for a further 1 year, so we can check whether the acne has come back. Throughout, patients will also be asked about how much isotretinoin treatment is costing them and the health service.
How often will the study visits happen, and how long will they be?
The first study visit will usually happen at the dermatology appointment when the decision to start isotretinoin is made. This is a longer study visit (45 minutes) so that any questions about the study can be answered, a written consent form can be completed, and information about a patient’s medical history is collected.
The rest of the study visits are designed to fit with normal dermatology appointments and happen 1 month after starting isotretinoin, then 3 months, 5-6 months, 8-10 months and 12 months. These need to be in person (ie not over the telephone). The study visits will not add much extra time, maybe 5 minutes for acne severity to be assessed.
What happens if I no longer want to take part in the study?
If a patient no longer wishes to take part in Acne-ID then they will be able to continue with their isotretinoin treatment under their usual dermatology team. Their isotretinoin treatment will not be affected.
As much as possible, we hope patients will be continue in the study as much as they are able to, because all the information is important.
Where is the study run from?
Around 20 dermatology clinics at hospitals across the UK will take part in the study. Nottingham University Hospitals NHS Trust will be the lead hospital.
When is the study starting and how long is it expected to run for?
The study will start in August 2024 for 18 months.
Who is funding the study?
The National Institute for Health and Care Research (NIHR), Health Technology Assessment (HTA) - www.nihr.ac.uk/research-funding/funding-programmes/health-technology-assessment
Who is the main contact for the study?