About Acne-ID
Acne affects most people at some point in their lifetime and the prevalence is greatest in adolescence and early adulthood. Skin changes in acne include comedones (blackheads and whiteheads) and inflammatory papules, nodules and cysts. Severe acne can be painful and bleed, as well as have a significant effect of wellbeing. Permanent scarring is more likely with severe acne but can occur with all acne severities. Acne is treated using a stepwise approach. After cream treatments and oral antibiotics, evidence-based options are limited and most patients with severe acne are treated with isotretinoin tablets.
Isotretinoin at the standard care dose is a highly effective treatment. However, there are potential side effects which impact daily life, can occasionally be serious and may lead to lower treatment satisfaction. Acne-ID will therefore provide new information on the advantages and disadvantages of a low-dose isotretinoin strategy. This information will be useful for patients and healthcare professionals in deciding the dosing of isotretinoin, and for the NHS when designing acne care services.
Trial summary
Acne-ID is a 2-arm, parallel-group, individually randomised, multicentre, non-inferiority trial with an internal pilot phase. There are two nested sub-studies, a health economic evaluation and a qualitative study to develop a clinical decision support tool.
We aim to recruit 800 people with acne aged 12 to 24 years over a 12 month period. Each participant will be followed up for 12months.
We will compare a low-dose isotretinoin strategy (the intervention) with standard care dosing (the comparator). All participants will take isotretinoin tablets every day (no placebo group). The treatment will stop when the first of the following happens
i) no new acne spots for at least 4 weeks
ii) reached a maximum cumulative dose
iii) taken isotretinoin for 12 months.
Primary outcome:
Acne clearance, defined by the Comprehensive Acne Severity Score, at the end of treatment course
Recruiting sites:
Acne-ID is a UK multicentre study which will recruit from approximately 20 hospital dermatology departments
Other outcomes:
These secondary outcomes were chosen to measure aspects of acne care which are important to patients and healthcare professionals: Acne clearance at different time points, Adverse effects and tolerability, Quality of life, Treatment satisfaction, Relapse of acne