Status:
COMPLETED
Short-term Topical Application to Prevent Atopic Dermatitis
Lead Sponsor:
University College Cork
Conditions:
Eczema Atopic Dermatitis
Eczema
Eligibility:
All Genders
Up to 5 years
Phase:
NA
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 ato...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT03871998
Start Date
April 16 2019
End Date
November 30 2021
Last Update
June 22 2022
Active Locations (1)
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1
Cork University Maternity Hospital
Cork, Ireland