Horimukai 2014.

Study characteristics
Methods	Study design: randomised, controlled, parallel‐group, investigator‐blinded trial Recruitment date: November 2010 to November 2013 Treatment arms: 2 AD follow‐up: 4 weeks, 12 weeks, 24 weeks, 32 weeks FA follow‐up: sensitisation to food and inhalants at 32 weeks
Participants	Randomised: N = 118 (intervention n = 59; control n = 59) Inclusion criteria:  Infant within the first week after birth High‐risk infant from atopic dermatitis (family history) Infant without treatment with corticosteroids Infant whose parents gave informed consent Exclusion criteria:  Infant treated with corticosteroid ointment (except genital and anal areas) Infant with skin lesions such as dyskeratosis or bullosa diagnosed by specialists in dermatology Small‐for‐gestational‐age (< 37 weeks) Infant with hepatic disease, convulsion, cardiac disease, haemophilia, diabetes, or autoimmune disease Inappropriate case as evaluated by doctors
Interventions	Intervention: emollient was applied each day for 32 weeks. Hanifin‐Rajka criteria were used to diagnose AD Comparator: control group applied petroleum jelly if desired Moisturiser/Emollient: emulsion‐type emollient (2e (Douhet) emulsion) from the first week of life; petroleum jelly was prescribed to each infant in both groups on request by the institutional review board
Outcomes	Primary outcomes: the cumulative rate of incidence of AD, eczema, or both by temporal observation. Modified UKWP criteria were applied by a dermatology specialist Secondary outcomes:  Specific IgE antibodies Transepidermal water loss (TEWL) Stratum corneum water concentration Stratum corneum pH Staphylococcus aureus on skin Onset of allergic disease such as asthma and food allergy Adverse events: “the dermatology specialist stopped giving the emollient to 3 infants whose skin lesions seemed to be the result of urticaria or contact dermatitis caused by emulsion‐type emollients (related adverse events). After several days, however, the doctor judged that these skin lesions were not adverse events because they disappeared rapidly, and similar lesions were not seen when the same emollients were used again. These 3 infants did not have AD/eczema or skin rash when they were followed for 32 weeks. There were no infants from families that withdrew consent who had skin lesions. In summary, adverse events caused by this emulsion‐type emollient were not observed during this RCT” No IPD are available on adverse events
Identification	Sponsorship source: supported in part by Health and Labour Sciences Research Grants for Research on Allergic Diseases and Immunology from the Ministry of Health, Labour and Welfare of Japan (H22‐Men'eki‐Ippan‐002 to H.S.; H25‐Nanchito‐Ippan‐001 to M.A. and H.S. as principal investigators) and grants from the National Center for Child Health and Development (20S‐1 to Y.O. and 23S‐3 to H.S.) Country: Japan Setting: National Center for Child Health and Development, the only national hospital for mothers and children in Tokyo
Declarations of interest	Extensive list in the trial publication
Notes