NCT05790330 Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
| NCT ID | NCT05790330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Atopic Dermatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-03-10 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-03-10 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT05790330 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790330 currently recruiting?
Yes, NCT05790330 is actively recruiting participants. Visit ClinicalTrials.gov or contact King's College London to inquire about joining.
Where is the NCT05790330 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05790330 clinical trial?
NCT05790330 is sponsored by King's College London. The trial plans to enroll 90 participants.
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