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

Recruitingn/aAges 0 Months - 6 MonthsAllKing's College London
NCT07228962 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 microbiom

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
St Thomas' Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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