Exploring the connection between skin inflammation and mental health in atopic eczema
'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
This study looks at how skin inflammation and itching in people with severe eczema affect their mental health and brain function to see if treating the eczema can improve their overall well-being.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05790330 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 to 18 with diagnosed atopic eczema requiring systemic treatment or those on topical therapy, as well as healthy controls.
Not a fit: Patients who do not have atopic eczema or those with contraindications to MRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of mental health issues associated with atopic eczema.
How similar studies have performed: While there is existing research on the connection between skin conditions and mental health, this specific approach examining the neurocutaneous axis in atopic eczema is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- Unit for Paediatric and Population-based Dermatology Research — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.