The PEBBLES study: Prevention of Eczema By a Barrier Lipid Equilibrium Strategy

Does twice daily application of a ceramide dominant cream (EpiCeram) for the first six months of life reduce the incidence of eczema by six months of age, when compared to standard skin care, in infants who have a family history of allergic disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000472774

Acronym

PEBBLES

Enrollment

Registered

2013-04-26

Start date

2013-05-08

Completion date

2014-07-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Asthma affects approximately 20% of children, is a common cause of hospital admissions, and we do not know how to stop children developing it. Infantile eczema is also common, affecting about a third of children. Infants with eczema often later develop asthma. It is hypothesised sensitisation to allergens can occur via damaged skin associated with eczema, which then increases the risk of asthma. If this hypothesis is correct, it may be possible to prevent asthma by improving the skin barrier function in infants. There is evidence that a ceramide based emollient (which contains the major components of skin) can improve skin barrier function, while current treatments for eczema do not. This study is aims to determine if twice daily application of a ceramide dominant emollient can improve infant skin barrier function and prevent the development of eczema in high risk children.

Interventions

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. Approximatly six gram

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

1 Days to 3 Weeks

Healthy volunteers

Yes

Inclusion criteria

Either mother and/or father has a self reported history of: - asthma and/or - eczema/atopic dermatitis and/or - hayfever/allergic rhinitis and/or - food allergy

Exclusion criteria

- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram. - Multiple births (twins, triplets etc.) - Premature infants (<36 weeks) - Infants with major birth or early life medical complications that require admission into a special care nursery. - Infants whose parents are not able to comply with all protocol required visits and procedures.

Outcome results