Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
Recruiting · NCT05790330 · Observational (researchers observe without assigning treatment) · Lead sponsor: King's College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
'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
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 therapy or healthy controls.
- 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.
- 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 questionnaires and complying with instructions during MRI scanning).
Exclusion criteria
- Insufficient understanding of the study by the patient and/or parent/guardian.
- 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.
- Any condition deemed by the Investigator to limit a patient's ability to undertake MRI components of the study, for example significant claustrophobia.
- Diagnosed by a sleep medicine specialist with a formal sleep disorder, requiring systemic medication.
- 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.
- Previous and/or current substance misuse.
- Patients who take medications that would, in the investigator's opinion, impact on quality of sleep studies.
Where it is running
1 location listed.
- Unit for Paediatric and Population-based Dermatology Research - London, United Kingdom