Data

PEBBLES study dataset 425 infant participants testing EpiCeram for eczema prevention

The University of Melbourne

Dataset description

These data are from participants enrolled into the PEBBLES study (n=425) including demographic data, skin barrier function and eczema examination at baseline, six weeks and 12 months of age following randomisation to intervention group, twice daily application of a skin carrier cream (EpiCeram) or control group.
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Source Study

Trial acronym

PEBBLES

Trial ID

ACTRN12617001380381

Purpose

Prevention

Phase

Phase 3

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

A/Prof Adrian Lowe

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 ....
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Key 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.

Key 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 ....
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Can healthy volunteers participate?

Yes

 

Population

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

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 ....
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Comparison

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.

Outcomes

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 ....
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Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Intervention group, outcome data, and potential predictors of outcome.

When will data be available?

from 1/10/2021 onwards (no end date)

Available to whom?

Academic researchers

Available for what types of analyses?

Grouped analyses or individual participant meta-analyses.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au