PEBBLES
ACTRN12617001380381
Prevention
Phase 3
Government body,National Health and Medical Research Council
A/Prof Adrian Lowe
The primary objective of this study is to demonstrate that twice daily application of a ceramide dominant emollient reduces the risk of eczema and food allergy, when compared to standard skin management. Secondary objectives are to determine if twice daily application of a ceramide dominant emollient reduces the risk of infants developing allergic sensitisation (as measured by skin prick test); to determine if twice daily application of a ceramide dominant emollient improves infant skin barrier .... Read more
Infants will be eligible for this study if their mother, father, or an older sibling has a self-reported history of at least one of the following conditions: asthma, eczema/atopic dermatitis, hay fever/ allergic rhinitis or food allergy.
Infants with any of the following will be excluded: A parent who has a known hypersensitivity to any of the ingredients of EpiCeram™ will be excluded, as it would be difficult for these parents to apply EpiCeram™ to their infant, and there is likely to be an increased risk of the infant reacting to the cream. Multiple births (twins, triplets etc.) will be excluded, due to the difficulty in randomising individual twins and because of the clustering effect of multiple children from the same family .... Read more
Yes
Sample Size 425
Min. age No limit
Max. age 3 Weeks
Sex Both males and females
Condition category Eczema/Atopic Dermatitis , Food Allergy
Condition code Inflammatory and Immune System , Skin
Intervention code Prevention , Treatment: Drugs
Twice daily use of a ceramide dominant cream (EpiCeram) to infants skin. Ingredients in the formulation are Capric Acid, Cholesterol, Citric Acid, Conjugated Linoleic Acid, Dimethicone, Disodium EDTA, E. Cerifera (Candelilla) Wax, Food Starch Modified Corn Syrup Solids, Glycerin, Glyceryl Stearate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Palmitic Acid, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Potassium Hydroxide, Purified Water, Sorbic Acid, Squalane, Xanthan Gum. Parents will be instr .... Read more
Control group Active
The study staff will not provide any directions to parents in the control arm on how to manage their child's skin. No attempt will be made to alter or influence parents treatment of their child's skin in this arm of the study. This is defined as standard skin care. Duration of care is 6 months.
Outcome: Presence of eczema as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema. Timepoint: 12 months of age.
Outcome: Confirmed diagnosis of food allergy at 12 months (52 weeks). This diagnosis is derived from a combination of allergic sensitisation, reaction history and food challenge. A skin prick test to six common allergens will be performed (egg white, cows’ milk, peanut, dust mite, cat dander, and rye grass) along with a negative (saline) and a positive (histamine) control. Participants that are sensitised to certain foods (>=1mm wheal) during the skin prick testing will be give .... Read more
yes
Intervention group, outcome data, and potential predictors of outcome.
from 1/10/2021 onwards (no end date)
Academic researchers
Grouped analyses or individual participant meta-analyses.