Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorKing's College London
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy babies and babies with atopic dermatitis up to 6 months old.
Ability of parents/guardians/caregivers to provide written informed consent for study participation.
Willingness of parents/guardians/caregivers to comply with all study requirements.
Parents/guardians/caregivers competent use of English language.
Disqualifiers
Parents/guardians/caregivers unable to give informed consent.
Preterm birth (defined as birth before 37 completed weeks gestation).
Significant inflammatory skin disease at birth.
Baby has any other serious health issue.
Trial population
Babies up to 6 months old with or without eczema that can attend St Thomas' Hospital
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Healthy babies
Group B: Babies with Eczema
Trial outcomes
Primary outcomes
1
Inflammatory Cytokine levels in ISF
The ISF extraction device will be applied to the baby's calf for a total of 5 min (both lesioned and non-lesioned skin in eczema presenting babies) and an ISF sample will be collected using an extraction gauze. The amount of protein or sodium will be used to determine the volume of ISF sampled. In addition, the release of soluble mediators such as IL-10 and TGF-beta as well as other Th1/Th2 cytokines IFN-Ɣ IL-1β IL-2 IL-4 IL-5 IL-13 IL-6 IL-8 (CXCL8) IL-10, IL-33, IL-12p70, TNF-α, GM-CSF, TSLP will be measured using an MSD cytokine analyser.
Time frame
At enrolmentSecondary outcomes
1
TEWL
TEWL, a validated measure of skin barrier function, will be measured using a closed chamber TEWL instrument (Biox Aquaflux Model AF200) near the ISF sampling site.
Time frame
At enrolment2
Microbiome profiles and Metabolite levels
Microbiome and metabolome swabs will be taken, in healthy babies just from one site, in those with eczema from both lesional and non-lesional skin.
Time frame
At enrolment3
Tolerability of the use of the ISF Device
Tolerability of the use of the non-invasive ISF device in babies with and without eczema will be assessed through a 5-point scale by the study team member, where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor. Photographs will be taken to record the observations. We will also measure tolerability quantitatively by measuring TEWL immediately after application of the device.
Time frame
At enrolment4
Investigator Assessments
Changes in the skin will be observed and recorded by the investigator, including the Eczema Area and Severity Index (EASI) scoring, on a scale of 0-72, where a higher score corresponds to more severe eczema.
Time frame
At enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Engineering and Physical Sciences Research Council, UK
Collaborator
Source ClinicalTrials.gov