Short-term Topical Application to Prevent Atopic Dermatitis
Condition: Eczema Atopic Dermatitis; Eczema; Eczema, Infantile; Food Allergy
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Food Hypersensitivity
Study type: Interventional

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.
    

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.
    

Intervention name(s): Skin barrier protection in the first 2 months of life
Intervention type(s): Other
Intervention description(s): Skin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application.
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)
Primary purpose: Prevention
Keywords: Eczema; Atopic dermatitis; Food allergy; Skin barrier; Filaggrin; Natural moisturizing factor; TEWL; Skin microbiome; Prevention; Moisturizer