None listed
Conditions
Brief summary
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 function; to determine the level of parental compliance with a program to build infant skin barrier function; to confirm that a ceramide dominant emollient does not cause adverse effects in infants; to determine the level of compliance required to demonstrate an improvement in infant skin barrier function and to determine if twice daily application of a ceramide dominant emollient influences infant skinmicrobial colonisation, or skin lipid profile. 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 seven hospitals. Treatment will be from birth until six months, with a six week, six month and twelve month follow-up. An initial assessment will be performed at baseline which incorporates three surveys, a skin assessment, diary card (which is to be completed weekly and measures compliance), a breast milk sample, guthrie card and tape stripping. The six week assessment entails a skin assessment, survey, compliance check, breast milk sample, tape stripping and guthrie card, while the six month assessment entails a survey. Primary outcomes are assessed at the 12 month follow up where in addition to the aforementioned items, a saliva sample will also be taken and skin prick testing and food challenges will be performed when children have a positive SPT to one or more foods. The primary and secondary outcomes are assessed again at the 4-year follow-up where in addition to the aforementioned items oscillometry testing will be performed to measured lung function.
Interventions
The PEBBLES trial involved the twice-daily application of a ceramide-dominant emollient (EpiCeram™) during early infancy. EpiCeram™ contains a formulation that includes 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 Wat
The PEBBLES trial involved the twice-daily application of a ceramide-dominant emollient (EpiCeram™) during early infancy. EpiCeram™ contains a formulation that includes 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, and Xanthan Gum. Parents were instructed to apply EpiCeram™ over their child's entire skin surface twice daily, with a recommended dosage of approximately 6 grams per application. This regimen was to be followed consistently, including after bathing the infant or at their regular bath time. The intervention aimed to assess the prophylactic effect of EpiCeram™ on infant skin barrier function over a treatment duration of six months. Following this period, the use of EpiCeram™ was discontinued by the parents, and the product is currently unavailable to the public in Australia due to its lack of Therapeutic Goods Administration approval. The ongoing PEBBLES 4-year follow-up is a continuation of the PEBBLES trial but with an observational study design. Only families who participated in the original PEBBLES trial will be invited to participate in the 4-year follow-up. This follow-up study includes a combination of online surveys and clinical assessments, which encompass lung function testing using Oscillometry, skin prick testing including foods (egg white, cows’ milk, peanut, cashew, and seafood) and airborne allergens (dust, cat hair, ryegrass, mixed grass and moulds), and the collection of biological samples (including skin lipids, skin microbiome, saliva, and finger prick blood samples). If a child is found to be sensitized to a food allergen, they will be invited to undergo an oral food challenge to confirm the presence of a food allergy.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Weeks
Healthy volunteers
Yes
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. All families who participated in the original PEBBLES trial will be invited to participate in the 4-year follow-up.
Exclusion criteria
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 which would reduce the effective sample size of the study. Who are born premature (<36 weeks) as the effect of the intervention may be different in premature infants. Who have major birth or early life medical complications that require admission into a special care nursery, as it will be difficult for parents to comply with the study requirements. Whose parents do not have sufficient English language skills to be able to answer questions. Whose parents are not able to comply with all protocol required visits and procedures. Whose parents have requested to withdraw from the study. Whose parents have requested not to be contacted for subsequent follow-ups.
Outcome results
None listed