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. 2021 Feb 5;2021(2):CD013534. doi: 10.1002/14651858.CD013534.pub2

Simpson 2014.

Study characteristics
Methods Study design: multi‐centre, multi‐national, assessor‐blind, randomised (1:1), controlled pilot trial (6 months)
Recruitment date: May 2010 and May 2011 
Treatment arms: 2
Follow‐up: 6 months; research nurse contacted parents by telephone at 10 days and 6 weeks, with a face‐to‐face visit at 12 weeks (usually at home in the UK and as a clinic visit in the USA). A further telephone call was made at 18 weeks, and the final contact was a clinic visit at 24 weeks 
Participants Randomised: N = 124 (intervention n = 64, control n = 60)
Inclusion criteria:

  1. High risk of eczema with a first‐degree relative with a clinical diagnosis of atopic dermatitis, asthma, or allergic rhinitis


Exclusion criteria: 

  1. Mother had taken Lactobacillus rhamnosus supplements during pregnancy

  2. Born before 37 weeks' gestation

  3. Major congenital anomaly

  4. Hydrops fetalis

  5. Immunodeficiency syndrome

  6. Severe genetic skin disorder

  7. Serious skin condition that would make the use of emollients inadvisable 
Interventions All parents were given a skin care advice booklet, which reflected current guidelines. Parents were advised to:

  1. avoid soap and bubble bath;

  2. use a mild, fragrance‐free synthetic cleanser designed specifically for babies;

  3. avoid bath oils and additives;

  4. use a mild, fragrance‐free shampoo designed specifically for babies, and avoid washing the suds over the baby's body; and

  5. avoid using baby wipes, when possible.


Intervention: parents were offered a choice of 3 emollients of different viscosities (an oil, a cream/gel, or an ointment)

  1. In the UK, sunflower seed oil, Doublebase Gel, and liquid paraffin 

  2. In the USA, sunflower seed oil, Cetaphil Cream, or Aquaphor Healing Ointment 


Preferred emollient used in the intervention group: cream/gel formulations (67.2%), oil (23.4%), ointment (9.4%). Parents were asked to apply the emollient to the baby's entire body surface, except for the scalp, starting as soon as possible after birth (within a maximum of 3 weeks) and continuing until the infant was 6 months of age  
Comparator: control arm was asked to use no emollients and was given the infant skin care advice booklet
Oil/Moisturiser/Emollient ingredients: sunflower seed oil (a high ratio of linoleic/oleic acid, William Hodgson and Co., Congleton, UK), Doublebase Gel (Dermal Laboratories, Hitchin, United Kingdom), liquid paraffin 50% in white soft paraffin (Cetaphil Cream, Galderma Laboratories, Fort Worth, Texas, USA), Aquaphor Healing Ointment (Beiersdorf, Chester, OH, USA)
Outcomes Age of onset of eczema and proportion of transient cases 
Incidence of emollient‐related adverse events
Cumulative incidence of eczema at 6 months, as determined by an investigator
Adverse events: adverse events, including accidents, infections, and reactions, were prompted for at all patient visits. Three superficial cutaneous infections occurred in each group; all were considered mild in nature. There were no reports of irritant or allergic contact dermatitis (p 821). There were no emollient‐related adverse events and no differences in adverse events between groups (Results section, Abstract). IPD contains 2 participants who had skin infections
Identification Country: UK and the USA
Setting: UK: acute NHS hospital trusts (Nottingham University Hospitals, Derby Hospitals, and United Lincolnshire Hospitals) and 1 GP surgery (Surgery @Wheatbridge, Chesterfield)
USA: Oregon Health & Science University Hospital and Clinics (Portland, Oregon)
Sponsorship source: National Institute for Health Research (NIHR) under its programme grants for Applied Research Programme (RP‐PG‐0407‐10177). United States–based contributions were made possible with funding from a Mentored Patient‐oriented Research Career Development Award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health (5K23AR057486). Support was also obtained from the Oregon Clinical and Translational Research Institute (OCTRI) and by grant number 5 KL2 RR024141‐04 from the National Center for Research Resources (NCRR; 5 KL2 RR024141‐04), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Research in the McLean Laboratory is funded by the Wellcome Trust (Programme Grant 092530/Z/10/Z and Strategic Award 098439/Z/12/Z). SJB holds a Wellcome Trust Intermediate Clinical Fellowship ‐ WT086398MA
Declarations of interest This study was funded by the National Institute for Health Research (RPPG‐0407‐10177). MJ Cork has received compensation from Almirall Pharmaceuticals for membership on its advisory board; has received or has grants pending from Almirall Pharmaceuticals; and has received payment for delivering lectures, as well as compensation for travel and other meeting‐related expenses, from Almirall, Astellas Pharma, and Steifel (a GlaxoSmithKline company). WHI McLean’s institution has received funding from the Wellcome Trust (WT086398MA), as has that of SJ Brown, who also received an honorarium for speaking at the AAAAI Annual Meeting in 2012 and 2013. Remaining study authors declare that they have no relevant conflicts of interest
Notes