Non-Invasive Skin Fluid Biomarkers in Babies with and without Eczema
Official title: Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies
Run by King's College London · NCT07228962 · Data updated 2026-11-12
This study tests whether a tiny, painless device can safely collect skin interstitial fluid from babies to see if eczema changes immune signals compared with healthy babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Months to 6 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT07228962 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Babies up to 6 months old, including both healthy infants and those diagnosed with atopic dermatitis.
✕Probably not a fit
Some participants may not derive direct clinical benefit and results may not directly inform individual care.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses a non-invasive micro-suction device to extract interstitial skin fluid (ISF) from babies to compare chemical signals in healthy skin versus skin affected by eczema. It aims to show the device is tolerable and capable of obtaining biomarker data without causing discomfort or skin damage. Researchers will analyze ISF, skin swabs, and tape strips to compare immune-related markers, microbiome, and metabolome between groups and between lesional and non-lesional skin in eczema cases. The study plans to enroll 30 infants (15 healthy, 15 with eczema) in a single visit of 1–1.5 hours, collecting demographic and clinical information, eczema severity (for affected infants), and ISF samples. Findings could illuminate signals involved in eczema inflammation and inform future prevention and treatment strategies.
Why it matters
Potential benefit: If successful, the study could identify skin biomarkers that help understand eczema in babies and guide the development of new prevention or treatment approaches.
How similar studies have gone: Previous work with non-invasive skin sampling has yielded insights in pediatric dermatology, supporting the feasibility of this approach, though this exact method in infants is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
St Thomas' Hospital
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Carsten Flohr — King's College London
- Study coordinator: Preeti Khurana
- Email: gstt.carestudy@nhs.net
- Phone: 020 7188 7188
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.