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

NCT03667651 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EpiCeram

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

Sponsors & Collaborators

Principal Investigators

  • Adrian J Lowe, Doctorate · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03667651 on ClinicalTrials.gov