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Trial record 13 of 965 for:    eczema

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 (STAR)

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ClinicalTrials.gov Identifier: NCT03143504
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Atopic Eczema Diagnostic Test: Skin Testing for Atopic eczema Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group design.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 2, 2017
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Single arm.
All participants in the same arm.
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.





Primary Outcome Measures :
  1. 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 [ Time Frame: at 4 weeks (+2 weeks), and at 12 months of age (± 1 ]
    As above

  2. 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). [ Time Frame: 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

  3. 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. [ Time Frame: (≤72 hours old) and at 4 weeks of age (+2 weeks) to predict onset of eczema by 12 months ]
    As above


Secondary Outcome Measures :
  1. Incidence of eczema (UK working party diagnosis) and 'skin rashes' (self-reported) in study participants by 12 months of age. [ Time Frame: 12 months ]
    As above

  2. 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. [ Time Frame: 12 months ]
    As above

  3. 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. [ Time Frame: measured at 4 weeks (+2 weeks) to predict onset of eczema by 12 months of age using mixed model regression analysis. ]
    As above

  4. 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 [ Time Frame: 12 months ]
    As above

  5. 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. [ Time Frame: 12 months ]
    As above

  6. Capture of parental satisfaction through participant questionnaires on (i) the potential for early diagnosis of skin conditions, (ii) skin care treatments, and (iii) the skin assessments used by this study [ Time Frame: 12 months ]
    As above



Information from the National Library of Medicine

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Ages Eligible for Study:   37 Weeks to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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:

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

Exclusion Criteria:

Mothers:

  1. <18 years old
  2. Known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
  3. Unable to satisfactory give informed consent for participation
  4. Multiple pregnancies
  5. Live greater than 5 miles from The University of Sheffield

    Babies:

  6. Admission to neonatal unit
  7. Major congenital malformations or limb defects
  8. Illness, social issues or logistical reason that at the discretion of the direct care team, will prevent comfortable trial participation by the family
  9. The baby is to be adopted
  10. Currently participating in an interventional clinical trial that interferes with the STAR study objectives
  11. >72 hours old -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143504


Contacts
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Contact: Simon Danby, PhD BSc 01142713843 s.danby@sheffield.ac.uk

Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 SJF
Contact: Simon Danby, PhD BSc    01142713843    s.danby@sheffield.ac.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03143504     History of Changes
Other Study ID Numbers: STH19479
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eczema
Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases