Clinical trial Recruiting at 1 site Observational Ages 0 Months to 6 Months

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.

More Atopic Dermatitis trials

Quick facts

Study typeObservational
Ages0 Months to 6 Months
SexAll
Enrollment30 (estimated)
SponsorKing's College London
Academic / other
Locations1 site (London)
StatusRecruiting
StartedMarch 31, 2026
Main results expectedDecember 30, 2026
Study endsJune 30, 2027
Registry record updatedAugust 5, 2026
Trial IDNCT07228962 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • IMG-007 for adults with moderate-to-severe atopic dermatitis.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.