Short-term Topical Application to Prevent Atopic Dermatitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 5 Days
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03871998
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University College Cork
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jonathan O'B Hourihane, MD
Principal Investigator Affiliation	University College Cork
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Ireland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eczema Atopic Dermatitis, Eczema, Eczema, Infantile, Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Experimental: Interventional arm

Skin barrier protection in the first 2 months of life.

No Intervention: Control arm

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

Interventions

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.

Contact a Trial Team

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International Sites

Cork University Maternity Hospital, Cork, Ireland

Status

Address

Cork University Maternity Hospital

Cork, ,

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