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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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  • Jonathan Hourihane,
  • Carol Ní Chaoimh,
  • Dhanis Lad,
  • Claudio Nico,
  • Gerwin J. Puppels,
  • X.F.Colin C. Wong,
  • John E. Common,
  • Deirdre Murray,
  • Alan Irvine
Jonathan Hourihane
University College Cork
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Carol Ní Chaoimh
University College Cork
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Dhanis Lad
University College Cork
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Claudio Nico
A-D Druk BV
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Gerwin J. Puppels
A-D Druk BV
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X.F.Colin C. Wong
Agency for Science Technology and Research
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John E. Common
Agency for Science Technology and Research
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Deirdre Murray
University College Cork
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Alan Irvine
University College Cork
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Abstract

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 321 infants 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.
07 Apr 2022Submitted to Allergy
08 Apr 2022Submission Checks Completed
08 Apr 2022Assigned to Editor
10 Apr 2022Reviewer(s) Assigned
29 Apr 2022Review(s) Completed, Editorial Evaluation Pending
11 May 2022Editorial Decision: Revise Minor
20 May 20221st Revision Received
23 May 2022Assigned to Editor
23 May 2022Submission Checks Completed