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Expression of interest: Site selection questionnaire

Email address: acne-id@nottingham.ac.uk

REC reference / IRAS project ID / ISCRTN: not available yet

Clinical Trials Unit: Nottingham Clinical Trials Unit

Sponsor: University of Nottingham

Funder: National Institute for Health Research (NIHR)

Recruitment Target: 800

Recruitment end date: not yet available

Synopsis

 Severe acne can be painful, lead to scarring and have a psychological impact. Clinical trials have shown that isotretinoin is an effective treatment for severe acne and therefore isotretinoin is included in the 2021 NICE guidance for the management of acne. However, trial evidence is lacking on whether a low daily dose is as effective at treating acne, and what the advantages and disadvantages are, in comparison to how it is currently prescribed (standard-dose). Understanding the advantages and disadvantages of low-dose is particularly relevant when there are ongoing concerns about the side effects of isotretinoin.The Acne-ID trial aims to recruit patients aged 12-24 years with severe acne who are about to start treatment with isotretinoin i.e. the clinical decision to start isotretinoin has already been made. Participants who give consent will be assigned randomly into two groups: 

1. Low-dose isotretinoin (0.2-0.3 mg/kg/day)
2. Standard-dose isotretinoin (>0.5mg/kg/day) 

The primary outcome is – Acne clearance at the end of treatment course as defined by the Comprehensive Acne Severity Score (CASS) “clear” or “almost clear”. 

Secondary outcomes are -

• Side effects and tolerability
• Change in mood
• Quality of life
• Treatment satisfaction
• Recurrence of acne
• Costs to patients and the NHS 

The key inclusion criteria for Acne-ID are -

• Age 12 years to 24 years
• Clinical diagnosis of severe acne (including acne at risk of scarring) of the face +/- trunk
• Acne that has failed to respond to at least one 12-week minimum course of oral antibiotics in combination with a topical treatment.
• Clinical decision to start treatment with oral isotretinoin.
• MHRA acknowledgment of risk form completed.
• Willing to be randomised to either treatment group.
• Willing and able to give consent or child assent with parental consent.
• Willing and able to complete the study questionnaires. 

Main exclusion criteria for Acne-ID are -

• Previous treatment with isotretinoin
• Acne fulminans, acne conglobata or other acne subtype unsuitable for higher dose strategy
• Contraindications for taking isotretinoin
• Pregnant or breastfeeding 

We are looking to recruit 800 participants from about 20 sites across the UK. We are looking for interested dermatology departments of all sizes and are actively seeking to represent the whole of the UK population. A few important points about the study are: 

• Clinicians need to be happy for their patients to be randomised to either dose
• This is a trial of isotretinoin dosing, and the decision to start isotretinoin has already been made
• Isotretinoin capsules of all doses (20mg, 10mg and 5mg) may need to be prescribed to ensure the dose is within the requirements of low-dose
• The baseline visit, when isotretinoin will be started, will need a member of the research team to consent the patient and collect baseline information (30-45 mins)
• Face-to-face clinical appointments will be required every 2 months so that an assessment of acne severity can be made
• Acne severity will be assessed by someone who is unaware which group the patient is in (i.e. not a clinician who has seen the patient before)
• Patients in the low-dose group may be on isotretinoin for longer (but this is not known)