NCT05790330Recruiting
Mind and Skin - the Neurocutaneous Axis 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
Source: ClinicalTrials.gov · Last updated 3 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
'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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 2 Sept 2022
- Start date
- 10 Mar 2023
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- King's College London
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05790330
What you commit to
- Study type: Observational
- Planned participants: 90
- From 10 Mar 2023 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previous and/or current substance misuse.
- Patients who take medications that would, in the investigator's opinion, impact on quality of sleep studies.
Other illness
- 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.
Other
- Insufficient understanding of the study by the patient and/or parent/guardian.
Who 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 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).
Age in the registry: 12 years to 18 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit for Paediatric and Population-based Dermatology Research Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.