Prevention of atopic dermatitis in high‐risk neonates via different types of moisturizer application: A randomized, blinded, parallel, three‐group, phase II trial (PAF study)

Abstract

BackgroundThe effectiveness of moisturizers in preventing infant atopic dermatitis (AD) remains unclear. We previously showed that using 2e moisturizer of commercial moisturizer (Shiseido Japan Co., Ltd.) at least once a day significantly prevented AD in infants as compared with as‐needed petroleum jelly. This trial aimed to determine the effectiveness of twice‐ or once‐daily application of Fam's Baby moisturizer (Fam's Inc.) in preventing AD compared with once‐daily 2e moisturizer.MethodsThis trial was a single‐centre, three‐parallel‐group, assessor‐blinded, superiority, individually randomized, controlled, phase II trial that was conducted from 25 August 2020 to 28 September 2021. We randomly assigned 60 newborns with at least one parent or sibling who has AD to receive Fam's Baby moisturizer twice daily (Group A) or once daily (Group B), or 2e once daily (Group C) in a 1:1:1 ratio until they were 32 weeks old. The primary outcome was the time of AD onset.ResultsAtopic dermatitis was observed in 11/20 (55%), 5/20 (25%) and 10/20 (50%), infants in Groups A, B and C, respectively. Cumulative incidence values for AD according to the Kaplan–Meier method showed that infants in Group B tended to maintain an intact skin for a longer period than those in Group C (median time, not reached [NR] vs. 212 days, log‐rank test, p = 0.064). Cox regression analysis showed that the risk of AD tended to be lower in Group B (hazard ratio with group C as control, 0.36; 95% confidential intervals: 0.12–1.06). No serious adverse events occurred in any of the enrolled infants.ConclusionFam's Baby moisturizer may better prevent AD than 2e. Further large‐scale trials should be performed to confirm the efficacy of Fam's Baby moisturizer in preventing AD in infants.

Skin‐centered strategies in food allergy prevention

“…Moreover, studies exploring the effect of emollients on the skin barrier usually required at least one application per day 65,70 and a recent study even showed that an emollient applied twice daily may have a stronger impact on AD prevention than applied once a day. 71 However, some protocols deviate from these practices without any evaluation of their equivalence in terms of skin barrier repair. For instance, the protocol used in the PreventADALL study was bathing infants for a maximum of 10 min with the addition of emulsified oil (paraffinum liquidum and trilaureth-4-phosphate) and application of an emollient only on the entire face, at least 4 days per week.…”

Prevention of AD in early childhood: Finding the right emollient and the right usage

“…In 2014, the group of Ohya showed that an emulsion type moisturizer 2e applied once daily during the first 32 weeks of life in neonates at high risk for AD reduced the risk of for eczema compared with Vaseline 1 . Later on, studies from other groups showed inconsistent findings and it was speculated that this may be due to different emollient types, frequency of application, bathing practices, and level of adherences 2,3 . In a new study in this issue of the JEADV the Ohya group examined the potential for AD prevention of two moisturizers from Japan.…”

“…In a new study in this issue of the JEADV the Ohya group examined the potential for AD prevention of two moisturizers from Japan. Moisturizer Fam's Baby was used twice daily, once a day after bathing (Group A), or once daily after bathing (Group B), compared to moisturizer 2e once daily after bathing (Group C) 2 . It was shown that Group B had the lowest risk for AD development.…”

“…1 Later on, studies from other groups showed inconsistent findings and it was speculated that this may be due to different emollient types, frequency of application, bathing practices, and level of adherences. 2,3 In a new study in this issue of the JEADV the Ohya group examined the potential for AD prevention of two moisturizers from Japan. Moisturizer Fam's Baby was used twice daily, once a day after bathing (Group A), or once daily after bathing (Group B), compared to moisturizer 2e once daily after bathing (Group C).…”

“…Moisturizer Fam's Baby was used twice daily, once a day after bathing (Group A), or once daily after bathing (Group B), compared to moisturizer 2e once daily after bathing (Group C). 2 It was shown that Group B had the lowest risk for AD development. Fam's Baby was better to prevent AD compared to the 2e moisturizer.…”