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 | Unknown

• 1 other identifier: STH19479
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 1) Changes in the molecular structure of the skin from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by in-vivo ATR-FTIR spectroscopy

  As above

  at 4 weeks (+2 weeks), and at 12 months of age (± 1

• Changes in skin barrier function from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).

  As above

  from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age assessed by TEWL (g/m2/h).

• Changes in desquamatory protease activity (nU μg-1) from birth (≤72 hours old) to 4 weeks (+2 weeks) and 12 months (±1 month) of age determined by ex-vivo laboratory assay.

  As above

  (≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months

Secondary Outcomes (6)

• Incidence of eczema (UK working party diagnosis) and 'skin rashes' (self-reported) in study participants by 12 months of age.

  12 months

• Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at birth (≤72 hours old) to predict onset of eczema by 12 months of age using mixed model regression analysis.

  12 months

• Diagnostic potential of in-vivo ATR-FTIR spectroscopy, TEWL and desquamatory protease activity measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.

  measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis.

• Incidence of filaggrin loss-of-function mutations within the study population determined by DNA genotyping, and its relationship with skin barrier development / eczema risk by 12 months of age

  12 months

• Capture of information through participant diaries and questionnaires to determine the interaction between the home environment and how parents care for their baby's skin in relation to skin barrier development / eczema risk by 12 months of age.

  12 months

Study Arms (1)

Single arm.

All participants in the same arm.

Diagnostic Test: Skin Testing for Atopic eczema

Interventions

Skin Testing for Atopic eczema DIAGNOSTIC_TEST

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.

Single arm.

Eligibility Criteria

• Age: 37 Weeks - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old

You may qualify if:

• Mothers 1) ≥18 years old 2) Carrying singleton pregnancies that are booked in to give birth at The Jessop maternity wing (Sheffield Teaching Hospitals NHS Foundation Trust) 3) Live within a 5 mile radius of The University of Sheffield
• Babies:
• \) Healthy, full-term babies (≥37 weeks gestation) ≤72 hours old

You may not qualify if:

• Mothers:
• \<18 years old
• Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
• Unable to satisfactory give informed consent for participation
• Multiple pregnancies
• Live greater than 5 miles from The University of Sheffield
• Babies:
• Admission to neonatal unit
• Major congenital malformations or limb defects
• Illness, social issues or logistical reason that at the discretion of the direct care team, will prevent comfortable trial participation by the family
• The baby is to be adopted
• Currently participating in an interventional clinical trial that interferes with the STAR study objectives
• \>72 hours old -

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 SJF, United Kingdom

Location

Related Publications (1)

• Chittock J, Kay L, Brown K, Cooke A, Lavender T, Cork MJ, Danby SG. Association between skin barrier development and early-onset atopic dermatitis: A longitudinal birth cohort study. J Allergy Clin Immunol. 2024 Mar;153(3):732-741.e8. doi: 10.1016/j.jaci.2023.10.017. Epub 2023 Nov 4.

  PMID: 37926123 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Skin tape-strips (d-squames) containing surface-only corneocytes (dead skin cells). Buccal (mouth) swabs. Microbiome swabs from the antecubital fossa (inner elbow joint)

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Simon G Danby, PhD, BSc

  University of Sheffield

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: May 8, 2017
• Study Start: March 2, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)