NCT03143504: STAR

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

Status unknown Last updated 18 April 2023

What this trial tests

trial testing Skin Testing for Atopic eczema in Atopic Eczema in 180 participants. Status unknown.

Timeline

2 March 2017

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Sheffield Teaching Hospitals NHS Foundation Trust
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	180
Start date	2 March 2017
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Skin Testing for Atopic eczema

Conditions studied

• Atopic Eczema — all drugs for Atopic Eczema →

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Who can join

Adults 37 Weeks to 13 Months, any sex, with Atopic Eczema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Cro S, Cornelius V, Lodrup Carlsen KC, et al · · 2021 · cited 43× · PMID 33545739 · DOI 10.1002/14651858.cd013534.pub2
2. Skin care interventions in infants for preventing eczema and food allergy.
   Kelleher MM, Phillips R, Brown SJ, Cro S, et al · · 2022 · cited 29× · PMID 36373988 · DOI 10.1002/14651858.cd013534.pub3
3. Association between skin barrier development and early-onset atopic dermatitis: A longitudinal birth cohort study.
   Chittock J, Kay L, Brown K, Cooke A, et al · · 2024 · cited 6× · PMID 37926123 · DOI 10.1016/j.jaci.2023.10.017
4. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148