Prevention of Eczema By a Barrier Lipid Equilibrium Strategy (PEBBLES) pilot study - Testing the compliance and saftey of a strategy for improving infant skin function.

In infants with a family history of allergic disease, is daily application of a ceramide dominant emollient for six weeks safe?

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000727246

Acronym

PEBBLES pilot study

Enrollment

Registered

2009-08-24

Start date

2010-03-09

Completion date

2010-06-16

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 pilot study is aims to determine if a daily application of a ceramide dominant emollient can improve infant skin barrier function.

Interventions

Daily use of a ceramide dominant cream (EpiCeram) to infants skin (excluding the infants face and hands). 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,

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Weeks 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.

Outcome results