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A Longitudinal Investigation of Skin Barrier Development From Birth and the Validation of Early Predictors of Atopic Eczema Risk: the Skin Testing for Atopic Eczema Risk (STAR) Study

NCT03143504 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2023-04-18

No results posted yet for this study

Summary

Eczema is a chronic disease of the skin that is becoming more common worldwide for reasons unknown. Currently the best indicator that a baby will suffer from eczema is if either or both parents have the condition, although this is not always the case. The goal of this study is to find out if, from birth, the skin of babies who later go on to suffer from eczema develops differently to those who do not. By doing this the research team hope to detect early signs of the disease within the first year of life. Our researchers will ask 150 families from the local Sheffield community to take part in a 1-year study.

To monitor baby skin development, the investigators will carry out 3 simple procedures at the skin surface that pose no risk to the baby. These procedures will be performed on the arm and thigh, at birth, 4 weeks, and 12 months of age. In addition the investigators will ask parents to answer questionnaires and fill out diaries at specific time points throughout the year, to collect information on how they care for their baby's skin. By recording which babies go on to, and do not, develop eczema the investigators hope to: (1) better understand baby skin development from birth, (2) identify if these simple procedures can predict the development of eczema during the first 12 months of life, and (3) investigate environmental effects that may cause disease onset. In a medical era where the prevention of eczema is the long-term goal, it is hoped that this study will provide a new way to identify babies that may go on to develop eczema. This will allow healthcare professionals to offer specific skin care advice from birth, and empower parents to take measured action to help prevent the emergence of eczema in their baby.

Conditions

  • Atopic Eczema

Interventions

DIAGNOSTIC_TEST

Skin Testing for Atopic eczema

FTIR Spectroscopy. This will involve placing the assessment tool briefly in contact with the baby's skin on the arm and thigh. Transepidermal Water Loss. This will involve placing a probe on the baby's skin for approximately 60 seconds on the arm and thigh. The probe measures the rate of water loss from the baby's skin, which indicates how well it acts as a barrier. Collection of skin samples. This will involve collecting surface skin samples using small sticky-tape discs to collect only the very top skin cells that are already dead and about to be shed naturally by the body. Microbial swab. The researchers will rub the baby's skin gently with a wet sterile swab to collect a sample of the microbes on the baby's skin surface. Buccal swab / saliva sample. The researchers will collect a sample of the baby's saliva using a buccal swab. This sample will be used to analyse the baby's genes (DNA) to assess their inherited risk of eczema.

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Simon G Danby, PhD, BSc · University of Sheffield

Eligibility

Min Age
37 Weeks
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143504 on ClinicalTrials.gov