Journal article

PEBBLES study protocol: A randomised controlled trial to prevent atopic dermatitis, food allergy and sensitisation in infants with a family history of allergic disease using a skin barrier improvement strategy

A Lowe, J Su, M Tang, CJ Lodge, M Matheson, KJ Allen, G Varigos, A Sasi, N Cranswick, S Hamilton, CF Robertson, J Hui, M Abramson, S O'Brien, S Dharmage

BMJ Open | BMJ PUBLISHING GROUP | Published : 2019

Abstract

Introduction The skin is an important barrier against environmental allergens, but infants have relatively impaired skin barrier function. There is evidence that impaired skin barrier function increases the risk of allergic sensitisation, atopic dermatitis (AD) and food allergy. We hypothesise that regular prophylactic use of emollients, particularly those that are designed to improve skin barrier structure and function, will help prevent these conditions. With the aim of determining if application of a ceramide-dominant emollient two times per day reduces the risk of AD and food allergy, we have commenced a multicentre phase III, outcome assessor blinded, randomised controlled trial of this..

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Grants

Awarded by National Health and Medical Research Council


Funding Acknowledgements

The PEBBLES study is investigator initiated; the University of Melbourne is the sponsor of the study. This work is supported by an NHMRC project grant (GNT1130010). Primus Pharmaceuticals, the manufacturer of EpiCeram has agreed to donate the intervention emollient to the study free of charge. Primus Pharmaceuticals will have no role in the collection, management, analysis and interpretation of data or decision to publish the study data.