Short-term Topical Application to Prevent Atopic Dermatitis

NCT ID: NCT03871998

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2021-11-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Interventional arm

Skin barrier protection in the first 2 months of life.

Group Type: EXPERIMENTAL

Skin barrier protection in the first 2 months of life

Intervention Type: 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.

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 5 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Hourihane

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan O'B Hourihane, MD

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons in Ireland

Locations

Cork University Maternity Hospital

Cork, , Ireland

Countries

Ireland

Other Identifiers

STOP AD

Identifier Type: -

Identifier Source: org_study_id