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Short-term Topical Application to Prevent Atopic Dermatitis (STOP AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871998
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : June 22, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan Hourihane, University College Cork

Brief Summary:
This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.

Condition or disease Intervention/treatment Phase
Eczema Atopic Dermatitis Eczema Eczema, Infantile Food Allergy Other: Skin barrier protection in the first 2 months of life Not Applicable

Detailed Description:

Eczema, also known medically as Atopic Dermatitis (AD) is the most common skin disease of childhood, affecting 20% of Irish children, and is a general term for a group of skin conditions that cause the skin to become dry, red, itchy and inflamed. AD is often the first manifestation of atopic comorbidities including food allergy, asthma and allergic rhinitis. Recently published studies suggest that skin barrier preservation, with topically applied moisturisers in the first year of life, reduces the incidence of AD. Our own data suggests that an earlier window for this skin barrier protection may exist.

This study is a randomised, open-label, controlled study and will investigate the effect of short-term neonatal skin barrier protection on the prevention of AD and food allergy in high risk infants. Infants with at least one parent with a positive history of atopic disease (AD, allergic rhinitis, asthma or food allergy) will be eligible for recruitment.

The first study visit will take place within approximately 4 days of birth in the postnatal wards. At this visit, infants will be randomised to either treatment with skin barrier protection using a commercially available moisturiser or to standard routine skincare with no moisturiser from as soon as possible after birth until 2 months of age. This visit will also involve measurements of neonatal trans-epidermal water loss (TEWL) and natural moisturising factor (NMF) to assess skin barrier function and structure. Skin swabs will also be taken for microbiome and immune biomarker analysis.

Follow-up assessments will take place at 2, 4 and 8 weeks, 6 and 12 months. Each visit will include a physical examination of the infant's skin, including TEWL and NMF measurements, and a questionnaire on infant health, bathing and skincare.

Infant skin swabs will be taken again at 8 weeks and 12 months. A research nurse or doctor, blind to treatment allocation, will administer standardised assessments for the presence (yes/no), extent and severity of AD at 6 and 12 months. Suspected cases of food allergy will be investigated using skin prick testing (SPT) and oral food challenges.

A DNA sample will be taken to test for filaggrin loss-of-function mutations, which are linked to AD risk.

The primary outcome is AD at 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, randomised, open-label, controlled study to evaluate whether short-term skin barrier protection using a moisturizer from birth to 2 months can prevent the onset of atopic dermatitis and food allergy at 12 months. Assessments of atopic dermatitis will be blinded.
Masking: Single (Outcomes Assessor)
Masking Description: Research personnel responsible for conducting atopic dermatitis assessments during study follow-up visits will be blinded to the treatment allocation.
Primary Purpose: Prevention
Official Title: Short-term Topical Application to Prevent Atopic Dermatitis
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Interventional arm
Skin barrier protection in the first 2 months of life.
Other: Skin barrier protection in the first 2 months of life
Skin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application.

No Intervention: Control arm
Standard skincare advice. No moisturiser in the first 2 months.



Primary Outcome Measures :
  1. Cumulative incidence of atopic dermatitis at 12 months. [ Time Frame: 12 months ]
  2. Cumulative incidence of IgE-mediated food allergy at 2 years [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months [ Time Frame: Birth to 12 months ]
    TEWL measured at birth, 2, 4 and 8 weeks and at 6 and 12 months.

  2. Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months. [ Time Frame: Birth to 12 months ]
    NMF measured by Raman spectroscopy at birth, 2, 4 and 8 weeks and at 6 and 12 months.

  3. Microbial diversity and richness of the cheek and antecubital fossa (study subset). [ Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Microbial community analysis (identification and abundance of a taxonomic units) will be used for the calculations of population diversity and richness indices (rarefaction, Shannon index, abundance-based coverage estimators (ACE), and Chao1) in a subset of study participants (n = 30 per study group).

  4. Changes in skin microbial diversity and richness over the first year of life. [ Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Comparison of microbial diversity and richness of the cheek and antecubital fossa between baseline, 8 weeks and 12 months (n = 30 per study group).

  5. Comparison of microbial diversity and richness between the intervention and control groups. [ Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Comparison of microbial diversity and richness of the cheek and antecubital fossa at each timepoint between the intervention (moisturiser) and control (no moisturiser) groups (n = 30 per study group).

  6. Skin biomarker profile analysis of the cheek and antecubital fossa (study subset). [ Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Cheek and antecubital fossa skin biomarker analysis, including interleukins, chemokines. and antimicrobial peptides (final list to be established) at birth, 8 weeks and 12 months (n = 30 from each study group).

  7. Changes in skin biomarker profile between study over the first year of life. [ Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Comparison of skin biomarker profiles of the cheek and antecubital fossa between baseline, 8 weeks and 12 months (n = 30 per study group).

  8. Comparison of skin biomarker profiles between the intervention and control groups. [ Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0-4 days), 8 weeks and 12 months. ]
    Comparison of skin biomarker profiles of the cheek and antecubital fossa at each timepoint between the intervention (moisturiser) and control (no moisturiser) groups (n = 30 per group).



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy full-term infants, gestational age >36+6 weeks.
  • Infant has at least one parent with self-reported atopic dermatitis, food allergy, allergic rhinitis or asthma.
  • Not requiring admission to the Neonatal Unit.

Exclusion Criteria:

  • No parental history of atopic disease.
  • Admission to the Neonatal Unit for issues other than the establishment of normal feeding.
  • Being administered oral or parenteral antibiotics.
  • Receiving phototherapy for hyperbilirubinaemia.
  • Sibling, including twin, already recruited.
  • Other serious health issues (e.g. abdominal wall defects, congenital heart disease etc.) or a severe widespread skin condition (e.g. collodion).
  • Any condition that would make the use of skin barrier protectant inadvisable or not possible (e.g. ankle talipes or developmental dysplasia of the hip, requiring a Pavlik's harness or casts).
  • Participation in any other clinical trial of an investigational medicinal product.

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): NCT03871998


Locations
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Ireland
Cork University Maternity Hospital
Cork, Ireland
Sponsors and Collaborators
University College Cork
Investigators
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Principal Investigator: Jonathan O'B Hourihane, MD Royal College of Surgeons in Ireland
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Responsible Party: Jonathan Hourihane, Principal Investigator, University College Cork
ClinicalTrials.gov Identifier: NCT03871998    
Other Study ID Numbers: STOP AD
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Hourihane, University College Cork:
Eczema
Atopic dermatitis
Food allergy
Skin barrier
Filaggrin
Natural moisturizing factor
TEWL
Skin microbiome
Prevention
Moisturizer
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Food Hypersensitivity
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases