Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies (CARE)

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:

1. 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).
2. Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema.
3. Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device.
4. 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Eczema; Atopic Dermatitis; Atopic Eczema

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Preeti Khurana; Phone Number: 57716 020 7188 7188; Email: gstt.carestudy@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Babies up to 6 months old with or without eczema that can attend St Thomas' Hospital

Description

Inclusion Criteria:

1. Healthy babies and babies with atopic dermatitis up to 6 months old.
2. Ability of parents/guardians/caregivers to provide written informed consent for study participation.
3. Willingness of parents/guardians/caregivers to comply with all study requirements.
4. Parents/guardians/caregivers competent use of English language.

Exclusion Criteria:

1. Parents/guardians/caregivers unable to give informed consent.
2. Preterm birth (defined as birth before 37 completed weeks gestation).
3. Significant inflammatory skin disease at birth.
4. Baby has any other serious health issue.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy babies; Babies up to 6 months old without eczema
Babies with Eczema; Babies up to 6 months old with eczema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At enrolment

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Guy's and St Thomas' NHS Foundation Trust; Engineering and Physical Sciences Research Council, UK
• Investigators: Principal Investigator: Carsten Flohr, King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Atopic Dermatitis; Skin Barrier; Dermatology; Eczema; Immune System; Interstitial Skin Fluid; Early life
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: 173024; EP/X013251/1 (Other Grant/Funding Number: Engineering & Physical Sciences Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No