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NCT Number: NCT07228962

Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device 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).

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Key information

Conditions

Eczema Atopic Dermatitis Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. TEWL

    Time frame: At enrolment

    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.

  2. Microbiome profiles and Metabolite levels

    Time frame: At enrolment

    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.

  3. Tolerability of the use of the ISF Device

    Time frame: At enrolment

    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.

  4. Investigator Assessments

    Time frame: At enrolment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Preeti Khurana

CONTACT

[email protected]

020 7188 7188 ext. 57716

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Engineering and Physical Sciences Research Council, UK
  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Official study title

Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies

Acronym: CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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