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Early initiation of short-term emollient use for the prevention of atopic dermatitis in high-risk infants-The STOP-AD randomised controlled trial

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posted on 2023-04-25, 15:46 authored by Carol Ní Chaoimh, Dhanis Lad, Claudio Nico, Gerwin J Puppels, X F Colin C Wong, John E Common, Deirdre M Murray, Alan D Irvine, Jonathan HourihaneJonathan Hourihane

Background: Protecting the skin barrier in early infancy may prevent atopic dermatitis (AD). We investigated if daily emollient use from birth to 2 months reduced AD incidence in high-risk infants at 12 months.

Methods: This was a single-center, two-armed, investigator-blinded, randomized controlled clinical trial (NCT03871998). Term infants identified as high risk for AD (parental history of AD, asthma or allergic rhinitis) were recruited within 4 days of birth and randomised 1:1 to either twice-daily emollient application for the first 8 weeks of life (intervention group), using an emollient specifically formulated for very dry, AD-prone skin, or to standard routine skin care (control group). The primary outcome was cumulative AD incidence at 12 months. AD <6 months was diagnosed based on clinical presence of AD. The UK Working Party Diagnostic Criteria were applied when diagnosing AD between 6 and 12 months.

Results: Three hundred twenty-one were randomised (161 intervention and 160 control), with 61 withdrawals (41 intervention, 20 control). The cumulative incidence of AD at 12 months was 32.8% in the intervention group vs. 46.4% in the control group, p = 0.036 [Relative risk (95%CI): 0.707 (0.516, 0.965)]. One infant in the intervention group was withdrawn from the study following development of a rash that had a potential relationship with the emollient. There was no significant difference in the incidence of skin infections between the intervention and control groups during the intervention period (5.0% vs. 5.7%, p > 0.05).

Conclusions: This study has demonstrated that early initiation of daily specialized emollient use until 2 months reduces the incidence of AD in the first year of life in high-risk infants.

Funding

City of Dublin Skin and Cancer Hospital

Skin Research Institute of Singapore (A*STAR- BMRC-EDBH17/01/a0/004)

Open access funding provided by IReL

History

Comments

Th original article is available at https://onlinelibrary.wiley.com/

Published Citation

Ní Chaoimh C, et al. Early initiation of short-term emollient use for the prevention of atopic dermatitis in high-risk infants - The STOP-AD randomised controlled trial. Allergy. 2023;78(4):984-994.

Publication Date

23 August 2022

PubMed ID

35997592

Department/Unit

  • Paediatrics

Publisher

John Wiley & Sons, Inc.

Version

  • Published Version (Version of Record)

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