The PEBBLES study – Testing a strategy for preventing eczema and food allergy in high risk infants

INTERVENTION: 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 instructed to apply EpiCeram™ to the full skin surface of their child twice per day. The prophylactic use of EpiCeram™ is the intervention that is being tested for its effect on infant skin barrier function. We will instruct parents to apply approximately 6 grams of EpiCeram™ per application at two regular times each day, including after bathing the infant, or at the time they would normally bathe their child. The PEBBLES study recruiter will demonstrate the application of the cream to parents during the baseline assessment. Duration of treatment is 6 months. Mothers will be asked to bring all tubes of cream (both used and unused) with them to all follow‐up assessments (when the child is approximately 6 weeks, and 6 months (26 weeks) of age), so that the study coordinator can weigh the remaining cream. This will allow for an estimate of the total amount of cream applied to the baby’s skin. We will also ask mothers how frequently cream was applied and how often applications were missed (Survey 4), and to complete a diary card documenting the days on which cream was applied (Diary Card – treatment group, Diary Card – no treatment group). Non‐adherence will be defined as using the study cream on average for less than five days per week (once per day). CONDITION: Eczema/Atopic Dermatitis Food Allergy PRIMARY 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 given a challenge to determine if they are allergic to those foods. This will be conducted at the MCRI Allergy Clinic under the supervision of a Doctor specifically trained in oral food challenges. Presence of eczema as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema. ; ; INCLUSION CRITERIA: 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. SECONDARY OUTCOME: Eczema severity assessed using the EASI score. Parent report of a community doctor diagnosis of eczema. Skin barrier function ‐ as assessed by Trans‐epidermal water loss. skin microbial colonisation and skin lipid profile as assessed by tape stripping Skin prick test reactivity to any of six allergens; (egg white, cows’ milk, peanut, dust mite, cat dander, and rye grass). Both a negative (saline) and a positive (histamine) control will be used. To confirm that a ceramide dominant emollient does not cause adverse effects in infants as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study. To determine the level of compliance required to demonstrate an improvement in infant skin barrier function as assessed by the parental completion of weekly diary cards and weighing of the tubes of study cream at each visit. To determine the level of parental compliance with a program to build infant skin barrier function as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit