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Prevention of atopic dermatitis in high-risk neonates via different types of moisturizer application: A randomized,
Y Inuzuka1, K Yamamoto-Hanada1, T Kobayashi2
1Allergy Center, National Center for Child Health and Development, Tokyo, Japan.
Insights
Fam's Baby moisturizer applied once daily may be more effective in preventing infant atopic dermatitis (AD) than a commercial alternative. Further research is needed to confirm these findings for infant skincare.
Area of Science:
- Dermatology
- Pediatrics
- Clinical Trials
Background:
- The effectiveness of moisturizers in preventing infant atopic dermatitis (AD) is not well-established.
- Previous research indicated that daily use of a commercial moisturizer (2e) prevented AD more effectively than petroleum jelly.
- This study evaluated Fam's Baby moisturizer for AD prevention in infants.
Purpose of the Study:
- To determine if twice- or once-daily application of Fam's Baby moisturizer is more effective in preventing infant atopic dermatitis (AD) compared to once-daily application of 2e moisturizer.
Main Methods:
- A single-center, assessor-blinded, randomized controlled trial involving 60 newborns with a family history of AD.
- Infants were assigned to receive Fam's Baby moisturizer twice daily (Group A), Fam's Baby moisturizer once daily (Group B), or 2e moisturizer once daily (Group C) until 32 weeks of age.
- The primary outcome measured was the time to AD onset.
Main Results:
- Atopic dermatitis (AD) occurred in 55% of infants in Group A, 25% in Group B, and 50% in Group C.
- Infants receiving Fam's Baby moisturizer once daily (Group B) showed a trend towards longer periods of intact skin compared to the 2e group (median time NR vs. 212 days).
- Cox regression analysis indicated a trend towards a lower risk of AD in Group B (HR 0.36; 95% CI 0.12-1.06) compared to Group C, with no serious adverse events reported.
Conclusions:
- Fam's Baby moisturizer, particularly with once-daily application, may offer superior prevention of infant atopic dermatitis (AD) compared to the 2e moisturizer.
- Larger-scale clinical trials are recommended to validate the efficacy of Fam's Baby moisturizer for infant AD prevention.
Background:
The 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.
Methods:
This 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.
Results:
Atopic 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.
Conclusion:
Fam'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.
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