drugset / Trial / NCT03667651

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

NCT03667651

Phase 3 Active not recruiting 760 enrolled University of Melbourne
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2018-03-06
Primary completion
2027-05-31
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator EpiCeram Unknown 6 g Topical