RecruitingPhase IVInterventional

Low-dose isotretinoin versus standard-dose isotretinoin to treat severe acne in young people – the Acne-ID study

Severe acne can be painful, cause permanent skin scarring, and deeply affect confidence and mood. Isotretinoin is an effective prescription medicine that works well to clear stubborn spots when other treatments have failed. However, most people who take it experience side effects, such as dry skin, chapped lips, or changes in mood. The Acne-ID trial compares two ways of taking isotretinoin. One group takes the usual standard dose over a shorter period. The other group takes a lower daily dose, possibly for a longer time. Researchers want to see if the lower dose clears acne just as well, reduces side effects, and keeps skin clear long-term. Young people aged 12 to 24 who have already agreed with their doctor to start isotretinoin can take part. Because the trial follows standard NHS care, there are no extra hospital visits required.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

University of Nottingham

Enrolment target

800

Start

01 Dec 2024

Estimated completion

31 Mar 2027

Acne

What is this study about?

Acne is very common during teenage and young adult years. For around 1 in 10 people, it becomes severe. Severe acne can lead to painful cysts, lifelong scarring, and feelings of anxiety or low mood. When typical creams and antibiotic tablets do not help, doctors often prescribe a strong, licensed medicine called isotretinoin.

Isotretinoin is very effective at clearing skin, but almost everyone who takes it experiences side effects. Common issues include very dry skin, cracked lips, nosebleeds, and muscle aches. Less often, it can affect mood or liver function. Because of these side effects, researchers want to see if giving a lower dose each day can clear acne just as well while making the treatment much easier to tolerate.

The Acne-ID study places young patients into one of two groups by chance. One group takes the standard daily dose, while the other takes a lower daily dose for a slightly longer time. Researchers will monitor how well the skin clears, whether spots return after treatment finishes, and how patients feel throughout their care.

The findings will help NHS doctors understand the safest, most comfortable way to prescribe isotretinoin in the future, giving young people better treatment options with fewer unpleasant side effects.

Key takeaways

Tests whether a lower daily dose of isotretinoin clears severe acne with fewer side effects.
Open to young people aged 12 to 24 who have already agreed with their doctor to start isotretinoin.
Fits directly into regular NHS hospital appointments with no extra visits needed.
Participants are randomly placed into either the standard dose or lower dose group.
Follows strict safety monitoring, including regular checks on mood, blood tests, and pregnancy prevention.

Who may be eligible?

This study is open to young people aged 12 to 24 who have severe acne on their face, chest, or back that could cause scarring. You and your specialist doctor must have already decided together that isotretinoin tablets are the right treatment for you. If you are under 16, a parent or guardian will need to give their permission alongside your agreement.

You cannot join the study if you have taken isotretinoin tablets before, or if you have a known allergy to the medicine. It is also not suitable for people with rare, sudden types of severe acne (such as acne fulminans) or those taking other medicines that cannot be safely mixed with isotretinoin.

Because isotretinoin can cause severe harm to an unborn baby, anyone who could become pregnant must strictly follow the NHS Pregnancy Prevention Programme. This involves using reliable contraception, taking monthly pregnancy tests, and signing an official safety agreement before starting.

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 aged between 12 and 24 years old?
Do you have severe acne on your face or body that could leave scars?
Have you and your doctor already agreed that isotretinoin is the right next treatment?
Have you never taken isotretinoin tablets in the past?
Are you willing to be placed into either dose group and fill out brief surveys about your wellbeing?

Answer every question to see your result.

What does participation involve?

Taking part in the Acne-ID study fits directly into your normal hospital clinic visits, meaning you will not have to attend extra appointments. If you agree to take part, a computer will assign you to either the standard dose or the lower dose. Neither you nor your doctor can choose the group, though your doctor can adjust your dose later if needed for your safety.

During your routine visits, your care team will examine your skin and carry out standard safety checks, including regular blood tests and pregnancy tests if relevant. You will also be asked to complete short questionnaires about your skin, how you are feeling, your mood, and any side effects you notice. Treatment usually lasts several months, followed by brief check-ins after you finish your tablets. Around 30 participants will also be invited to take part in an optional interview about their experiences.

Potential risks and benefits

The main benefit of taking part is helping doctors find a gentler way to treat severe acne, with the possibility of experiencing fewer side effects if you receive the lower dose. Because isotretinoin is already standard NHS care, the medical risks are the same as taking the drug outside of a trial. Side effects can include dry skin, chapped lips, eye irritation, muscle aches, and mood changes. Your medical team will monitor you closely at every step. Joining is entirely your choice, and you are free to leave the trial at any time without it affecting your NHS medical care.

Locations (29)

Queens Medical Centre, Nottingham University Hospital
City only
Nottingham, England
Ashford Hospital
Approximate
Ashford, England
Harrogate & District NHS Foundation Trust
City only
Harrogate, England
Norfolk & Norwich Hospital Laboratory
City only
Norwich, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Epsom and St Helier University Hospitals NHS Trust
Unverified
Carshalton, England
Chesterfield Royal Hospital NHS Foundation Trust
Unverified
Chesterfield, England
Pinderfields General Hospital
Unverified
Wakefield, England
University Hospitals Bristol and Weston NHS Foundation Trust
Unverified
Bristol, England
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, England
London North West University Healthcare NHS Trust
Unverified
Harrow, England
Brighton and Sussex University Hospitals NHS Trust
Unverified
Brighton, England

Common questions

Will I have to travel for extra hospital appointments?

No. The trial is designed to match your routine NHS care, so all check-ups happen during your standard clinic visits.

Can I pick which dose of isotretinoin I take?

No. A computer randomly assigns you to either the standard or lower dose group to make sure the trial results are completely fair.

What happens if I get severe side effects during the trial?

Your doctor will manage side effects exactly as they would in routine care. They can lower your dose, pause treatment, or stop it entirely if needed.

Why are the pregnancy rules so strict?

Isotretinoin causes severe damage to developing babies. Under UK safety rules, anyone able to get pregnant must use reliable contraception and take regular tests.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point without giving a reason, and your doctor will continue treating your acne as normal.

How to find out more

Esther Burden-Teh

esther.burden-teh@nottingham.ac.uk +44 (0) 115 84 68631 Official trial record

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