Atopic DermatitisNCT05790330
Mind and Skin - the Neurocutaneous Axis in Atopic Eczema
An observational study of Atopic Dermatitis, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Methotrexate and Dupilumab
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Mar 2023to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Child, Adult
Study population: Group 1: Patients aged 12-18 who have been diagnosed with eczema and require systemic therapy. Group 2: Patients aged 12-18 who have been diagnosed with eczema and require topical therapy only. Group 3: Patients aged 12-18 who do not have eczema.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Unit for Paediatric and Population-based Dermatology Research
London, SE17EH
Carsten Flohr, 020 7188 7188 ext. 57716, carsten.flohr@kcl.ac.uk
About this study
Official title: '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
'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.
Read the detailed description
Atopic eczema is an intensely itchy skin disease which often starts in infancy or early childhood. It can have profound effects on patients' quality of life and cause long-lasting psychological impairment. Sleep may be very disturbed. More severe disease often requires oral/injectable immuno-modulatory treatments (i.e. medications which control symptoms by influencing the immune system).
There is an association between eczema, impaired cognitive functioning and mental health disorders, but the underlying mechanisms are not clearly defined.
This projects examines the links between inflammation-driven itching and disturbed sleep, and how this might be causally responsible for systemic and brain inflammation, disturbance of cognitive functioning and mental health problems. The investigators will also study potential changes occurring following an improvement in eczema when patients are treated with systemic immuno-modulators.
Key investigations will include:
- Home-based sleep studies using a commercially available sleep devices (for example DREEM headband, Philips Actiwatch, oximetry) ii) Structural and functional magnetic resonance imaging (MRI) of the brain, iii) Blood tests to quantify systemic inflammation iv) Genetic analyses, particularly related to the immune system, circadian rhythm (the "internal 24-hour clock"), skin barrier function and the risk of developing eczema or associated diseases, v) Assessments of the skin's barrier function vi) Stool samples and skin swabs to study the gut and skin microbiome.
The investigators will utilise existing anonymised data for comparative purposes (e.g. from patients with Attention Deficit Hyperactivity Disorder (ADHD) and healthy controls who previously had brain imaging.)
The investigators will explore eczema patients' and families' perception of their disease, in particular itch and the resulting sleep loss, through focus groups, to better understand the sociological impact of eczema, and how these patients' interactions with the external world and society are affected by eczema. Importantly, this will include exploration of family dynamics, as patients with eczema often have profound sleep disturbance from early life, which can impact on their caregivers' sleep and quality of life.
- Conditions
- Atopic Dermatitis
- Being tested
- Methotrexate, Dupilumab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
As per usual standard of care
DupilumabDrug
As per usual standard of care
| Study group | Role | What they receive |
|---|---|---|
| Severe eczema | Patients aged 12-18 who have been diagnosed with atopic eczema and require starting systemic therapy. Receives: Drug: Methotrexate; Drug: Dupilumab | |
| Less severe eczema | Patients aged 12-18 who have been diagnosed with atopic eczema and require topical steroid therapy only. | |
| Healthy controls | Patients ages 12-18 who do not have atopic eczema. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) Score
Clinical assessment of atopic dermatitis disease activity. Range 0-72 (72 being the most severe outcome)
Measured: 6 months
Peak Pruritus Numerical Rating Score
Patient reported itch severity. Range 0-10 (10 being the worst outcome)
Measured: 6 months
Transepidermal water loss (TEWL)
Skin barrier function measurement using a device which measures the amount of water that passively evaporates through skin to the external environment due to water vapor pressure gradient on both sides of the skin barrier
Measured: 6 months
Skin surface pH
Skin barrier function measurement using a pH measuring device.
Measured: 6 months
Metabolome swab
Skin metabalome analysis using a skin swab
Measured: 6 months
Skin ELISA (enzyme-linked immunosorbent assay) and serum ELISA
Immunoassay detection and quantification
Measured: 6 months
RNA sequencing of blood serum
To detect transcript isoforms, gene fusions and single nucleotide variants.
Measured: 6 months
Pediatric Sleep Questionnaire
Sleep questionnaire. Score 18-126 (126 being the worst clinical outcome)
Measured: 6 months
Morningness-Eveningness Questionnaire
Sleep questionnaire. Score 16-86 assesses individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day.
Measured: 6 months
Patient-Reported Outcomes Measurement Information System (PROMIS)
Sleep questionnaire. Score 0-20 (0 being the worst clinical outcome)
Measured: 6 months
Pittsburgh Sleep Quality Index
Sleep questionnaires. Score 0-21 (21 being the worst clinical outcome)
Measured: 6 months
Dreem headband electroencephalogram monitoring
Sleep study - Measures brain activity to assess sleep cycles
Measured: 6 months
Polysomnography
Sleep study incorporating electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances.
Measured: 6 months
Actigraphy Watch analysis
Watch is worn by participant which records movement during sleep to analyse sleep pattern
Measured: 6 months
EMFIT mattress analysis
Mattress sensor which records movement during sleep to analyse sleep pattern to analyse sleep pattern
Measured: 6 months
Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II) Score
Intelligence Quotient Test. Score 40-160 (40 being the worst clinical outcome)
Measured: 6 months
Go/No-GO Task
The Go/No-go task requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials. This is scored as a fraction of correct responses.
Measured: 6 months
Simon Task
In this task participants are asked to respond to visual stimuli by making a rightward response to one stimulus (e.g. a circle) and a leftward response to another (e.g. a square). This is scored as a fraction of correct responses.
Measured: 6 months
Continuous Performance Task
In this task participants are asked to only respond to a specific sequence of visual stimuli. This is scored as a fraction of correct responses.
Measured: 6 months
Time Discrimination Task
In this task participants are ask to decide which stimuli stayed on screen for the longest duration. This is scored as a fraction of correct responses.
Measured: 6 months
Vigilance Task (Mackworth Clock)
In this task participants are asked to watched a clock hand that moves every second around the clock. From time to time the hand skips a second and participants need to respond to this. This is scored as a fraction of correct responses.
Measured: 6 months
Performance on Working Memory Task
Completed in functional MRI
Measured: 6 months
Performance on Sustained Attention Task
Completed in functional MRI
Measured: 6 months
Resting Brain State
Measured in functional MRI
Measured: 6 months
Structural Changes in the Brain
Structure of the brain is measured in MRI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start10 Mar 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790330
- Sponsor's protocol ID
- 280154
- Status last verified
- May 2024
- First submitted
- 2 Sep 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '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
- ClinicalTrials.gov ID
- NCT05790330
- Acronym / sponsor ID
- 280154
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Detailed description
Atopic eczema is an intensely itchy skin disease which often starts in infancy or early childhood. It can have profound effects on patients' quality of life and cause long-lasting psychological impairment. Sleep may be very disturbed. More severe disease often requires oral/injectable immuno-modulatory treatments (i.e. medications which control symptoms by influencing the immune system).
There is an association between eczema, impaired cognitive functioning and mental health disorders, but the underlying mechanisms are not clearly defined.
This projects examines the links between inflammation-driven itching and disturbed sleep, and how this might be causally responsible for systemic and brain inflammation, disturbance of cognitive functioning and mental health problems. The investigators will also study potential changes occurring following an improvement in eczema when patients are treated with systemic immuno-modulators.
Key investigations will include:
- Home-based sleep studies using a commercially available sleep devices (for example DREEM headband, Philips Actiwatch, oximetry) ii) Structural and functional magnetic resonance imaging (MRI) of the brain, iii) Blood tests to quantify systemic inflammation iv) Genetic analyses, particularly related to the immune system, circadian rhythm (the "internal 24-hour clock"), skin barrier function and the risk of developing eczema or associated diseases, v) Assessments of the skin's barrier function vi) Stool samples and skin swabs to study the gut and skin microbiome.
The investigators will utilise existing anonymised data for comparative purposes (e.g. from patients with Attention Deficit Hyperactivity Disorder (ADHD) and healthy controls who previously had brain imaging.)
The investigators will explore eczema patients' and families' perception of their disease, in particular itch and the resulting sleep loss, through focus groups, to better understand the sociological impact of eczema, and how these patients' interactions with the external world and society are affected by eczema. Importantly, this will include exploration of family dynamics, as patients with eczema often have profound sleep disturbance from early life, which can impact on their caregivers' sleep and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe eczema | – | Drug: Methotrexate, Drug: DupilumabPatients aged 12-18 who have been diagnosed with atopic eczema and require starting systemic therapy. |
| Less severe eczema | – | –Patients aged 12-18 who have been diagnosed with atopic eczema and require topical steroid therapy only. |
| Healthy controls | – | –Patients ages 12-18 who do not have atopic eczema. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Group 1: Patients aged 12-18 who have been diagnosed with eczema and require systemic therapy. Group 2: Patients aged 12-18 who have been diagnosed with eczema and require topical therapy only. Group 3: Patients aged 12-18 who do not have eczema.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAs per usual standard of care | Drug | Severe eczema |
| DupilumabAs per usual standard of care | Drug | Severe eczema |
Primary outcome
Eczema Area and Severity Index (EASI) Score
Time frame: 6 months
Clinical assessment of atopic dermatitis disease activity. Range 0-72 (72 being the most severe outcome)
Peak Pruritus Numerical Rating Score
Time frame: 6 months
Patient reported itch severity. Range 0-10 (10 being the worst outcome)
Transepidermal water loss (TEWL)
Time frame: 6 months
Skin barrier function measurement using a device which measures the amount of water that passively evaporates through skin to the external environment due to water vapor pressure gradient on both sides of the skin barrier
Skin surface pH
Time frame: 6 months
Skin barrier function measurement using a pH measuring device.
Metabolome swab
Time frame: 6 months
Skin metabalome analysis using a skin swab
Skin ELISA (enzyme-linked immunosorbent assay) and serum ELISA
Time frame: 6 months
Immunoassay detection and quantification
RNA sequencing of blood serum
Time frame: 6 months
To detect transcript isoforms, gene fusions and single nucleotide variants.
Pediatric Sleep Questionnaire
Time frame: 6 months
Sleep questionnaire. Score 18-126 (126 being the worst clinical outcome)
Morningness-Eveningness Questionnaire
Time frame: 6 months
Sleep questionnaire. Score 16-86 assesses individual differences in morningness and eveningness - the degree to which respondents are active and alert at certain times of day.
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: 6 months
Sleep questionnaire. Score 0-20 (0 being the worst clinical outcome)
Pittsburgh Sleep Quality Index
Time frame: 6 months
Sleep questionnaires. Score 0-21 (21 being the worst clinical outcome)
Dreem headband electroencephalogram monitoring
Time frame: 6 months
Sleep study - Measures brain activity to assess sleep cycles
Polysomnography
Time frame: 6 months
Sleep study incorporating electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances.
Actigraphy Watch analysis
Time frame: 6 months
Watch is worn by participant which records movement during sleep to analyse sleep pattern
EMFIT mattress analysis
Time frame: 6 months
Mattress sensor which records movement during sleep to analyse sleep pattern to analyse sleep pattern
Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II) Score
Time frame: 6 months
Intelligence Quotient Test. Score 40-160 (40 being the worst clinical outcome)
Go/No-GO Task
Time frame: 6 months
The Go/No-go task requires participants to respond by pressing a button when they see a "go" signal, and not respond when they see the "no-go" signal. The key behaviour measured with this experiment is the participants' ability to withhold a response on No-go trials. This is scored as a fraction of correct responses.
Simon Task
Time frame: 6 months
In this task participants are asked to respond to visual stimuli by making a rightward response to one stimulus (e.g. a circle) and a leftward response to another (e.g. a square). This is scored as a fraction of correct responses.
Continuous Performance Task
Time frame: 6 months
In this task participants are asked to only respond to a specific sequence of visual stimuli. This is scored as a fraction of correct responses.
Time Discrimination Task
Time frame: 6 months
In this task participants are ask to decide which stimuli stayed on screen for the longest duration. This is scored as a fraction of correct responses.
Vigilance Task (Mackworth Clock)
Time frame: 6 months
In this task participants are asked to watched a clock hand that moves every second around the clock. From time to time the hand skips a second and participants need to respond to this. This is scored as a fraction of correct responses.
Performance on Working Memory Task
Time frame: 6 months
Completed in functional MRI
Performance on Sustained Attention Task
Time frame: 6 months
Completed in functional MRI
Resting Brain State
Time frame: 6 months
Measured in functional MRI
Structural Changes in the Brain
Time frame: 6 months
Structure of the brain is measured in MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Unit for Paediatric and Population-based Dermatology Research
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) Score (time frame: 6 months). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.