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).

NCT Number	NCT07228962
Lead Sponsor	King's College London Collaborators: Guy's and St Thomas' NHS Foundation Trust, Engineering and Physical Sciences Research Council, UK
Conditions	Eczema, Atopic Dermatitis, Atopic Eczema
Enrollment	30 participants
Start Date	2026-03-31
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-05