Mind and Skin - the Neurocutaneous Axis in Atopic Eczema

Last updated: May 1, 2024
Sponsor: King's College London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hives (Urticaria)

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Treatment

Methotrexate

Dupilumab

Clinical Study ID

NCT05790330
280154
  • Ages 12-18
  • All Genders

Study Summary

'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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 12 to 18 with atopic eczema (groups 1 and 2), which has been diagnosedby a Consultant Dermatologist.
  2. Patients with atopic eczema warranting systemic immuno-modulatory therapy or patientswith atopic eczema on topical therapy or healthy controls.
  3. Written informed consent for study participation obtained from the patient or from theparent(s) / legal guardian, with assent as determined by the patient's age and levelof understanding.
  4. Willingness to comply with all study requirements.
  5. Competent use of English language, according to patient's age (patients will berequired to understand the written questionnaires and complying with instructionsduring MRI scanning).

Exclusion

Exclusion Criteria:

  1. Insufficient understanding of the study by the patient and/or parent/guardian.
  2. Any clear contra-indication to MRI scanning. In particular this would be due to thepresence of any implanted devices or metal from previous surgery or accident. Thiswould be fully assessed with a standardised safety questionnaire by a radiographerprior to MRI scanning.
  3. Any condition deemed by the Investigator to limit a patient's ability to undertake MRIcomponents of the study, for example significant claustrophobia.
  4. Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiringsystemic medication.
  5. Sleep disturbance from co-morbid illness (including physical and/ormental/psychological illness) other than atopic eczema, deemed by the Investigator tosignificantly impact on sleep components of the study.
  6. Previous and/or current substance misuse.
  7. Patients who take medications that would, in the investigator's opinion, impact onquality of sleep studies.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Methotrexate
Phase:
Study Start date:
March 10, 2023
Estimated Completion Date:
June 01, 2027

Study Description

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.

Connect with a study center

  • Unit for Paediatric and Population-based Dermatology Research

    London, SE17EH
    United Kingdom

    Active - Recruiting

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