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ACTIVE NOT RECRUITING
NCT03667651
PHASE3

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

Sponsor: University of Melbourne

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 3 Weeks

Study Type

INTERVENTIONAL

Enrollment

760

Start Date

2018-03-06

Completion Date

2027-05-31

Last Updated

2023-05-10

Healthy Volunteers

Yes

Interventions

DRUG

EpiCeram

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

Locations (4)

Mercy Women's Hospital

Heidelberg, Victoria, Australia

Frances Perry Private Hospital

Parkville, Victoria, Australia

Murdoch Children's Research Institute

Parkville, Victoria, Australia

Royal Women's Hospital

Parkville, Victoria, Australia