At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Methotrexate (drug), Dupilumab (drug)
- How long the study runs
- Study runs about 51 months (dates as stated)
- About the drug or intervention
- Methotrexate — drug: As per usual standard of care · Dupilumab — drug: As per usual standard of care
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 12 Years to 18 Years
- Who
- All
- Number of participants
- 90
- Started
- 2023-03-10
- Last checked
- 2024-05
Plain English Summary
What is this study?
- • Testing a new treatment for atopic dermatitis
- • Clinical study - 90 participants
- • 'Mind and Skin': A prospective cohort study evaluating the impact of inflammation, itch and sleep disturbance on the brain, mental health and cognition, in patients with severe atopy
Who can take part?
- • Ages 12 Years to 18 Years
- • Diagnosed with atopic dermatitis
Where?
- • London - Unit for Paediatric and Population-based Dermatology Research
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
'Mind and Skin': A prospective cohort study evaluating the impact of inflammation, itch and sleep disturbance on the brain, mental health and cognition, in patients with severe atopy.
More detail
Atopic eczema is an intensely itchy skin disease which often starts in infancy or early childhood. It can have profound effects on patients' quality of life and cause long-lasting psychological impairment. Sleep may be very disturbed. More severe disease often requires oral/injectable immuno-modulatory treatments (i.e. medications which control symptoms by influencing the immune system). There is an association between eczema, impaired cognitive functioning and mental health disorders, but the underlying mechanisms are not clearly defined. This projects examines the links between inflammation-driven itching and disturbed sleep, and how this might be causally responsible for systemic and brain inflammation, disturbance of cognitive functioning and mental health problems. The investigators will also study potential changes occurring following an improvement in eczema when patients are treated with systemic immuno-modulators. Key investigations will include: i) Home-based sleep studies using a commercially available sleep devices (for example DREEM headband, Philips Actiwatch, oximetry) ii) Structural and functional magnetic resonance imaging (MRI) of the brain, iii) Blood tests to quantify systemic inflammation iv) Genetic analyses, particularly related to the immune system, circadian rhythm (the "internal 24-hour clock"), skin barrier function and the risk of developing eczema or associated diseases, v) Assessments of the skin's barrier function vi) Stool samples and skin swabs to study the gut and skin microbiome. The investigators will utilise existing anonymised data for comparative purposes (e.g. from patients with Attention Deficit Hyperactivity Disorder (ADHD) and healthy controls who previously had brain imaging.) The investigators will explore eczema patients' and families' perception of their disease, in particular itch and the resulting sleep loss, through focus groups, to better understand the sociological impact of eczema, and how these patients' interactions with the external world and society are affected by eczema. Importantly, this will include exploration of family dynamics, as patients with eczema often have profound sleep disturbance from early life, which can impact on their caregivers' sleep and quality of life.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 18 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ to understand the written questionnaires and complying with instructions during MRI scanning)
What the study is looking for
- ✓Patients aged 12 to 18 with atopic eczema (groups 1 and 2), which has been diagnosed by a Consultant Dermatologist.
- ✓Patients with atopic eczema warranting systemic immuno-modulatory therapy or patients with atopic eczema on topical...
- ✓Written agreement to take part for study participation obtained from the patient or from the parent(s) / legal guardian,...
- ✓Willingness to comply with all study requirements.
- ✓Competent use of English language, according to patient's age (patients will be required to understand the written...
Who cannot take part
- ✗Insufficient understanding of the study by the patient and/or parent/guardian.
- ✗Any condition deemed by the Investigator to limit a patient's ability to undertake MRI components of the study, for...
- ✗Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiring systemic medication.
- ✗Previous and/or current substance misuse.
- ✗Patients who take medications that would, in the investigator's opinion, impact on quality of sleep studies.
See the full criteria
Where Is This Study? (1 UK site)
Unit for Paediatric and Population-based Dermatology Research
London SE17EH, United Kingdom