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

NCT07228962 | Not Yet Recruiting

• 2 other identifiers: 173024EP/X013251/1
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 eczema and propose new preventative strategies and effective treatments. Specifically, it aims to:

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

Conditions

Eczema; Atopic Dermatitis; Atopic Eczema

Keywords

Eczema; Atopic Dermatitis; Immune System; Skin Barrier; Dermatology; Interstitial Skin Fluid; Microbiome; Early life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• TEWL

  At enrolment

• Microbiome profiles and Metabolite levels

  At enrolment

• Tolerability of the use of the ISF Device

  At enrolment

• Investigator Assessments

  At enrolment

Study Arms (2)

Healthy babies

Babies up to 6 months old without eczema

Babies with Eczema

Babies up to 6 months old with eczema

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Engineering and Physical Sciences Research Council, UK: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin ISF samples - for immune marker, cytokine and metabolite analysis Skin Swabs - for skin microbiome and metabolome analysis These samples will be stored until all analysis for this study is complete before being disposed of in accordance with national Research Governance guidelines.

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Carsten Flohr

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Preeti Khurana

CONTACT

020 7188 7188; gstt.carestudy@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2025-10