Exploring the connection between skin inflammation and mental health in atopic eczema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates how inflammation, itching, and sleep disturbances in patients with severe atopic eczema affect brain function, mental health, and cognition. It aims to understand the mechanisms linking these factors and their impact on quality of life. The study will utilize home-based sleep monitoring, MRI imaging of the brain, blood tests for inflammation, genetic analyses, and assessments of skin barrier function. Additionally, it will evaluate changes in cognitive and mental health outcomes following treatment with systemic immuno-modulatory therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

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 the presence of any implanted devices or metal from previous surgery or accident. This would be fully assessed with a standardised safety questionnaire by a radiographer prior to MRI scanning.
3. Any condition deemed by the Investigator to limit a patient's ability to undertake MRI components of the study, for example significant claustrophobia.
4. Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiring systemic medication.
5. Sleep disturbance from co-morbid illness (including physical and/or mental/psychological illness) other than atopic eczema, deemed by the Investigator to significantly 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 on quality of sleep studies.

Where it's running

• Unit for Paediatric and Population-based Dermatology Research
  London, United Kingdom Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tilrekimig for moderate-to-severe eczema in teens and adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.