NCT03667651

The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants

THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 3 Weeks
• Healthy volunteers: Accepted

Summary

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 three hospitals.

Detailed description

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 skin microbial 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 three 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 and six month assessments entail a skin assessment, survey, compliance check, breast milk sample, tape stripping and guthrie card. 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..

Conditions

• Eczema
• Asthma
• Allergy;Food

Interventions

Type	Name	Description
DRUG	EpiCeram	Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.

Timeline

• Start date: 2018-03-06
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2018-09-12
• Last updated: 2023-05-10

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study