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

Sponsor
King's College London
Study ID
NCT07228962
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Months - 6 Months
Healthy Volunteers
Accepted

Study Details

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).

Key Dates

First listed
Nov 14, 2025
Start date
Mar 31, 2026
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Healthy babies
    Babies up to 6 months old without eczema
  • Arm: Babies with Eczema
    Babies up to 6 months old with eczema

Primary Outcome Measure

Inflammatory Cytokine levels in ISF [ Time Frame: At enrolment ]

Central Contacts

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Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

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