NCT03871998.

Study name	Short‐term Topical Application to Prevent Atopic Dermatitis (STOP AD)
Methods	Single‐centre, randomised, open‐label, controlled study
Participants	242 participants
Interventions	Experimental: intervention arm Skin barrier protection in the first 2 months of life No intervention: control arm Standard skin care advice. No moisturiser in the first 2 months
Outcomes	Primary outcomes Cumulative incidence of atopic dermatitis at 12 months [Time Frame: 12 months] Cumulative incidence of IgE‐mediated food allergy at 2 years [Time Frame: 2 years] Secondary outcomes Longitudinal changes in transepidermal water loss (TEWL) from birth to 12 months [Time Frame: Birth to 12 months] Longitudinal changes in natural moisturising factor (NMF) in the stratum corneum from birth to 12 months [Time Frame: Birth to 12 months] Microbial diversity and richness of the cheek and antecubital fossa (study subset) [Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months] Changes in skin microbial diversity and richness over the first year of life [Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months] Comparison of microbial diversity and richness between intervention and control groups [Time Frame: Skin swabs for microbiome analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months] Skin biomarker profile analysis of the cheek and antecubital fossa (study subset) [Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months] Changes in skin biomarker profile between studies over the first year of life [Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months] Comparison of skin biomarker profiles between intervention and control groups [Time Frame: Skin swabs for biomarker analysis will be taken at baseline (0 to 4 days), 8 weeks, and 12 months]
Starting date	12 March 2019
Contact information	Carol Ní Chaoimh ‐ cnichaoimh@ucc.ie Mairead Murray ‐ mairead.murray@ucc.ie
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