Lowe 2019.

Study name	PEBBLES study protocol: a randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy
Methods	Multicentre, phase III, outcome assessor‐blinded, randomised controlled trial
Participants	Aim: to recruit 760
Interventions	Intervention: 2 times per day treatment with EpiCeram (intervention group). EpiCeram has been approved for use by patients with AD or eczema by the US Food and Drug Administration (FDA) but does not yet have Australian Therapeutic Goods Administration (TGA) approval and is not currently available in Australia. Parents will be instructed to apply approximately 6 g of EpiCeram per application 2 times per day from birth until the infant is 6 months of age. Comparator: standard skin care advice (control group)  Parents of children in the control group will be managed as per existing practice and will not be given any emollients. For ethical reasons, parents of children in the control group will not be told to withhold skin care from their infant, and information related to use of emollients will be collected from all participants. Compliance: a weekly diary will be completed online by parents, who will document the frequency of EpiCeram application and use of any other creams
Outcomes	Primary outcomes: Presence of AD in the first 12 months of life assessed using UK Working Party criteria or visible AD at the time of examinations, or both Food allergy, based on skin prick tests, history of reactions, and food challenge at 12 months Secondary outcomes:  Adverse reaction to EpiCeram Skin barrier function as assessed by TEWL at 6 weeks and 12 months Food sensitisation (positive skin prick test) at 12 months of age Presence of observed AD that first presents from 6 to 12 months (incident after intervention period) Presence of probable AD within first year of life based on parent report of doctor‐diagnosed AD IgE‐associated AD (AD in the context of a positive skin prick test) AD severity assessed using the Eczema Area and Severity Index (EASI)
Starting date	October 2015 Update July 2021. Delays secondary to COVID‐19, results due end of 2022
Contact information	Adrian Lowe; lowea@unimelb.edu.au
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