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Randomized Controlled Trial
. 2021 Nov;62(4):e539-e545.
doi: 10.1111/ajd.13703. Epub 2021 Aug 23.

Moisturisers from birth in at-risk infants of atopic dermatitis - a pragmatic randomised controlled trial

Pamela Si Min Ng  1 , Lynette Wei Yi Wee  2 , Valerie Pui Yoong Ho  2 , Weixuan Colin Tan  2 , Priya Bishnoi  2 , Uma Alagappan  2 , Sharon Mun Yee Wong  2 , Emily Yiping Gan  2 , Bin Huey Quek  3 , Liang Shen  4 , Bing Su  5 , John Ea Common  6 , Mark Jean Aan Koh  2
Affiliations
Randomized Controlled Trial

Moisturisers from birth in at-risk infants of atopic dermatitis - a pragmatic randomised controlled trial

Pamela Si Min Ng et al. Australas J Dermatol. 2021 Nov.

Abstract

Background: Atopic dermatitis (AD) is a common, chronic dermatosis, with onset of disease often manifesting in early infancy. Past studies evaluating the early use of moisturisers in the prevention of AD had mixed results.

Objectives: To compare the incidence of moderate or severe AD and total incidence of AD in a cohort of 'at-risk' infants treated with moisturisers from the first 2 weeks of life, to a similar group without moisturisers.

Methods: We performed a single-centre, prospective, parallel-group, randomised study in infants with at least 2 first-degree relatives with atopy. Subjects were randomised into either a treatment group with moisturisers or a control group without moisturisers. Participants were assessed at 2, 6, and 12 months for AD and if present, the severity was assessed using SCORAD index. We also compared the overall incidence of AD, trans-epidermal water loss (TEWL), stratum corneum (SC) hydration, pH, and incidence of food and environmental sensitisation and allergies between both groups. Genotyping for loss-of-functions mutations in the FLG gene was conducted.

Results: A total of 200 subjects were recruited, with 100 subjects in each arm. There was no significant difference in incidence of moderate or severe AD, and total incidence of AD at 12 months between the treatment and control groups. There was a lower mean SCORAD in the treatment group than in the control group, but no significant difference in TEWL, SC hydration, and skin pH. No significant side-effects were reported.

Conclusions: The early use of moisturisers in 'at-risk' infants does not reduce the incidence of moderate-to-severe AD and overall incidence of AD in infancy.

Keywords: atopic dermatitis; ceramide; filaggrin; food sensitisation; moisturiser.

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Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Total incidence of moderate and severe AD at each study visit between treatment and control groups.
Figure 3
Figure 3
Mean SCORAD score over time in treatment and control groups.
Figure 4
Figure 4
(a) Mean TEWL readings over time in treatment and control groups. (b) Mean SC hydration readings over time in treatment and control groups. (c) Mean skin pH readings over time in treatment and control groups.
Figure 5
Figure 5
Incidence of food sensitisation and/or allergies between treatment and control groups. (a) Positive SPT results in the treatment group. (b) Positive SPT results in the control group.
See this image and copyright information in PMC

References

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