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The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
Sponsor: University of Melbourne
Summary
This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of three hospitals.
Official title: THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Key Details
Gender
All
Age Range
Any - 3 Weeks
Study Type
INTERVENTIONAL
Enrollment
760
Start Date
2018-03-06
Completion Date
2027-05-31
Last Updated
2023-05-10
Healthy Volunteers
Yes
Conditions
Interventions
EpiCeram
Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.
Locations (4)
Mercy Women's Hospital
Heidelberg, Victoria, Australia
Frances Perry Private Hospital
Parkville, Victoria, Australia
Murdoch Children's Research Institute
Parkville, Victoria, Australia
Royal Women's Hospital
Parkville, Victoria, Australia