P.A.R.A.D.E.S Study V1.0
Research type
Research Study
Full title
Patient-reported outcome measures (PROMS) for depression, self-harm and suicidality in adolescents and young adults: establishing their clinical utility, acceptability, and feasibility for use in acne clinical trials.
IRAS ID
317708
Contact name
Damian Wood
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Acne is associated with low mood , psychological distress and impaired quality of life. Acne and mental health problems such as depression, self-harm and suicidality are common in adolescents and young adults (AYA) Acne is the commonest skin condition affecting AYA, with 20-40% reporting severe acne.
There are limited treatment options for those with severe acne. Oral Isotretinoin is an effective acne therapy and is licensed for use in severe acne. However, despite its effectiveness its use is limited by safety concerns. Reports of an association with low mood and depression have led to specific concerns around self-harm and suicidality in patients treated with isotretinoin for severe acne.
Experts in acne research have recommended a standardised set of outcomes which should be used in clinical research trials of acne, therapies and these include measures of adverse events such as symptoms of depression, self harm, suicidality however, there are currently no recommended instruments to monitor these mental health adverse events in AYA.
Patient Reported Outcome Measures (PROMs) are standardised sets of questions researchers can use to measure patients’ perceptions of their health.
Despite the wide range of freely available and validated PROMS for measuring depression, self harm and suicidality in AYA, there is no agreement as to which are the most useful acne trials involving AYA. This can make it difficult to rely on or interpret the results of acne trials or compare the results of one research trial with another. We will conduct focus groups with adolescents and young adults, researchers, clinicians and parents/carers to decide which of the freely available PROMS measuring depression, self harm and suicide are most useful, acceptable and feasible for use in clinical research trials of acne therapies.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/PR/0878
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion