Short-term Topical Application to Prevent Atopic Dermatitis

NCT03871998 | Completed

• 1 other identifier: STOP AD
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema Atopic Dermatitis; Eczema; Eczema, Infantile; Food Allergy

Keywords

Eczema; Atopic dermatitis; Food allergy; Skin barrier; Filaggrin; Natural moisturizing factor; TEWL; Skin microbiome; Prevention; Moisturizer

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of atopic dermatitis at 12 months.

  12 months

• Cumulative incidence of IgE-mediated food allergy at 2 years

  2 years

Secondary Outcomes (8)

• Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months

  Birth to 12 months

• Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months.

  Birth to 12 months

• Microbial diversity and richness of the cheek and antecubital fossa (study subset).

  Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.

• Changes in skin microbial diversity and richness over the first year of life.

  Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.

• Comparison of microbial diversity and richness between the intervention and control groups.

  Skin swabs for microbiome analysis will be taken at baseline (0-4 days), 8 weeks and 12 months.

Study Arms (2)

Interventional arm

EXPERIMENTAL

Skin barrier protection in the first 2 months of life.

Other: Skin barrier protection in the first 2 months of life

Control arm

NO INTERVENTION

Standard skincare advice. No moisturiser in the first 2 months.

Interventions

Skin barrier protection in the first 2 months of life OTHER

Skin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application.

Interventional arm

Eligibility Criteria

• Age: 0 Days - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Maternity Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic; Food Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan O'B Hourihane, MD

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research personnel responsible for conducting atopic dermatitis assessments during study follow-up visits will be blinded to the treatment allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 12, 2019
• Study Start: April 16, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

IE (1)