EczemaCARENCT07228962
Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies
An observational study of Eczema and Atopic Dermatitis, run by King's College London at 1 site in United Kingdom.
Trial summary
This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of… Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Eczema, Atopic Dermatitis, Atopic Eczema
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2026to 30 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 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Babies up to 6 months old with or without eczema that can attend St Thomas' Hospital
Who may be able to join
- Healthy babies and babies with atopic dermatitis up to 6 months old.
- Ability of parents/guardians/caregivers to provide written informed consent for study participation.
- Willingness of parents/guardians/caregivers to comply with all study requirements.
- Parents/guardians/caregivers competent use of English language.
Who cannot join
- Parents/guardians/caregivers unable to give informed consent.
- Preterm birth (defined as birth before 37 completed weeks gestation).
- Significant inflammatory skin disease at birth.
- Baby has any other serious health issue.
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
St Thomas' Hospital
London, SE1 7EH
Preeti Khurana, PhD, 020 7188 7188 ext. 57716, gstt.cutie.study@nhs.net
About this study
Official title: Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies
This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments.
Specifically, it aims to:
- Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation).
- Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema.
- Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device.
- Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).
Read the detailed description
Eczema is a skin condition that affects up to 20% of children worldwide, and its numbers are increasing. Our goal is to learn more about eczema by studying how immune signals in the skin differ between babies with eczema and those with healthy skin. To do this, investigators will gently use a non-invasive device to extract a tiny amount of fluid from the top layer of baby's skin(Interstitial Skin Fluid). By studying these samples, investigators want to compare the immune signals of healthy skin and skin affected by eczema. This research aims to deepen our understanding of why eczema causes inflammation and to identify the specific signals involved in this process, particularly in babies.
A total of 30 babies will be recruited, of which 15 will be healthy and 15 have eczema. They will be invited to attend for one visit lasting 1-1.5 hours. During the study visit, clinical information such as demographics, medical history and co-morbidities as well as eczema treatments (where applicable) and other skin care practices will be collected. For babies that have eczema, an eczema area and severity index (EASI) assessment will be conducted. For all participants enrolled onto the study, Interstitial Skin Fluid (ISF) samples will be extracted from the skin using a painless, non-invasive device that is well-tolerated and will not cause any pain or skin damage to the baby. Samples for assessing the skin microbiome will be collected, including skin swabs and tape strips taken in a pain-free manner. Skin barrier function assessments such as Transepidermal water loss (TEWL) will also be performed helping us understand how well the baby's skin holds onto moisture. This is a painless and non-invasive device that doesn't cause any discomfort to the baby.
- Conditions
- Eczema, Atopic Dermatitis, Atopic Eczema
- Keywords
- Eczema, Atopic Dermatitis, Immune System, Skin Barrier, Dermatology, Interstitial Skin Fluid, Microbiome, Early life
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy babies | Babies up to 6 months old without eczema | |
| Babies with Eczema | Babies up to 6 months old with eczema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Cytokine levels in ISF
The ISF extraction device will be applied to the baby's calf for a total of 5 min (both lesioned and non-lesioned skin in eczema presenting babies) and an ISF sample will be collected using an extraction gauze. The amount of protein or sodium will be used to determine the volume of ISF sampled. In addition, the release of soluble mediators such as IL-10 and TGF-beta as well as other Th1/Th2 cytokines IFN-Ɣ IL-1β IL-2 IL-4 IL-5 IL-13 IL-6 IL-8 (CXCL8) IL-10, IL-33, IL-12p70, TNF-α, GM-CSF, TSLP will be measured using an MSD cytokine analyser.
Measured: At enrolment
Secondary outcomes (4)
TEWL
TEWL, a validated measure of skin barrier function, will be measured using a closed chamber TEWL instrument (Biox Aquaflux Model AF200) near the ISF sampling site.
Measured: At enrolment
Microbiome profiles and Metabolite levels
Microbiome and metabolome swabs will be taken, in healthy babies just from one site, in those with eczema from both lesional and non-lesional skin.
Measured: At enrolment
Tolerability of the use of the ISF Device
Tolerability of the use of the non-invasive ISF device in babies with and without eczema will be assessed through a 5-point scale by the study team member, where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor. Photographs will be taken to record the observations. We will also measure tolerability quantitatively by measuring TEWL immediately after application of the device.
Measured: At enrolment
Investigator Assessments
Changes in the skin will be observed and recorded by the investigator, including the Eczema Area and Severity Index (EASI) scoring, on a scale of 0-72, where a higher score corresponds to more severe eczema.
Measured: At enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start31 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 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, Engineering and Physical Sciences Research Council, UK
- Responsible party
- Sponsor
- Investigators
- Carsten Flohr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228962
- Sponsor's protocol ID
- 173024
- Other IDs
- EP/X013251/1
- Acronym
- CARE
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies
- ClinicalTrials.gov ID
- NCT07228962
- Acronym / sponsor ID
- CARE / 173024
- Conditions
- Eczema, Atopic Dermatitis, Atopic Eczema
- Keywords
- Eczema, Atopic Dermatitis, Immune System, Skin Barrier, Dermatology, Interstitial Skin Fluid, Microbiome, Early life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Engineering and Physical Sciences Research Council, UK
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Nov 2025 (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.
This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments.
Specifically, it aims to:
- Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation).
- Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema.
- Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device.
- Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).
Detailed description
Eczema is a skin condition that affects up to 20% of children worldwide, and its numbers are increasing. Our goal is to learn more about eczema by studying how immune signals in the skin differ between babies with eczema and those with healthy skin. To do this, investigators will gently use a non-invasive device to extract a tiny amount of fluid from the top layer of baby's skin(Interstitial Skin Fluid). By studying these samples, investigators want to compare the immune signals of healthy skin and skin affected by eczema. This research aims to deepen our understanding of why eczema causes inflammation and to identify the specific signals involved in this process, particularly in babies.
A total of 30 babies will be recruited, of which 15 will be healthy and 15 have eczema. They will be invited to attend for one visit lasting 1-1.5 hours. During the study visit, clinical information such as demographics, medical history and co-morbidities as well as eczema treatments (where applicable) and other skin care practices will be collected. For babies that have eczema, an eczema area and severity index (EASI) assessment will be conducted. For all participants enrolled onto the study, Interstitial Skin Fluid (ISF) samples will be extracted from the skin using a painless, non-invasive device that is well-tolerated and will not cause any pain or skin damage to the baby. Samples for assessing the skin microbiome will be collected, including skin swabs and tape strips taken in a pain-free manner. Skin barrier function assessments such as Transepidermal water loss (TEWL) will also be performed helping us understand how well the baby's skin holds onto moisture. This is a painless and non-invasive device that doesn't cause any discomfort to the baby.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy babies | – | –Babies up to 6 months old without eczema |
| Babies with Eczema | – | –Babies up to 6 months old with eczema |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Babies up to 6 months old with or without eczema that can attend St Thomas' Hospital
Key inclusion criteria (4 listed)
- Healthy babies and babies with atopic dermatitis up to 6 months old.
- Ability of parents/guardians/caregivers to provide written informed consent for study participation.
- Willingness of parents/guardians/caregivers to comply with all study requirements.
- Parents/guardians/caregivers competent use of English language.
Key exclusion criteria (4 listed)
- Parents/guardians/caregivers unable to give informed consent.
- Preterm birth (defined as birth before 37 completed weeks gestation).
- Significant inflammatory skin disease at birth.
- Baby has any other serious health issue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory Cytokine levels in ISF
Time frame: At enrolment
The ISF extraction device will be applied to the baby's calf for a total of 5 min (both lesioned and non-lesioned skin in eczema presenting babies) and an ISF sample will be collected using an extraction gauze. The amount of protein or sodium will be used to determine the volume of ISF sampled. In addition, the release of soluble mediators such as IL-10 and TGF-beta as well as other Th1/Th2 cytokines IFN-Ɣ IL-1β IL-2 IL-4 IL-5 IL-13 IL-6 IL-8 (CXCL8) IL-10, IL-33, IL-12p70, TNF-α, GM-CSF, TSLP will be measured using an MSD cytokine analyser.
4 secondary outcomes
TEWL
Time frame: At enrolment
Microbiome profiles and Metabolite levels
Time frame: At enrolment
Tolerability of the use of the ISF Device
Time frame: At enrolment
Investigator Assessments
Time frame: At enrolment
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 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Carsten Flohr principal investigator
King's College London
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 Eczema and 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 4 inclusion and 4 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 5 Aug 2026. 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?
Contact Preeti Khurana (020 7188 7188 ext. 57716, gstt.carestudy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Cytokine levels in ISF (time frame: At enrolment). 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 5 Aug 2026.