Related Experiment Video
Updated: Sep 6, 2025

Resolving Water, Proteins, and Lipids from In Vivo Confocal Raman Spectra of Stratum Corneum through a Chemometric Approach
Published on: September 26, 2019
Effective Primary Prevention of Atopic Dermatitis in High-Risk Neonates via Moisturizer Application: Protocol for a
Yusuke Inuzuka1, Kiwako Yamamoto-Hanada1, Kyongsun Pak2
1Allergy Center, National Center for Child Health and Development, Tokyo, Japan.
Insights
Twice daily application of Fam's Baby™ moisturizer may be more effective than once daily application for preventing atopic dermatitis (AD) in infants. This study compares Fam's Baby™ and 2e moisturizers to find optimal prevention strategies.
Area of Science:
- Dermatology
- Neonatal Care
- Clinical Trials
Background:
- Atopic dermatitis (AD) is a chronic inflammatory skin condition impacting infant quality of life.
- Previous findings on moisturizer 2e for AD prevention are inconsistent, necessitating further research.
- Optimal moisturizer type and application frequency for infant AD prevention remain undetermined.
Purpose of the Study:
- To compare the efficacy of twice daily versus once daily application of Fam's Baby™ moisturizer.
- To evaluate once daily application of 2e moisturizer as a control.
- To determine the optimal moisturizer regimen for preventing AD in neonates and infants.
Main Methods:
- A single-center, phase II, randomized controlled trial involving 60 newborns.
- Participants are assigned to one of three groups: Fam's Baby™ twice daily, Fam's Baby™ once daily, or 2e once daily.
- The primary outcome is the time to the first onset of AD.
Main Results:
- This section is not available in the provided abstract.
- Further research is needed to determine the efficacy of different moisturizer application frequencies.
- The study aims to inform future phase III trials for definitive conclusions.
Conclusions:
- This trial is the first in Japan to assess Fam's Baby™ for AD prevention in infants.
- Results will guide a potential phase III study on optimal AD prevention through moisturizers.
- The study anticipates contributing to reduced AD prevalence and healthcare costs.
Background:
Atopic dermatitis (AD) is a chronic and inflammatory skin disease that causes health-related burdens associated with pruritus and poor quality of life. Our previous study demonstrated that moisturizer (2e) application has a primary preventive effect on AD. However, this effect was not observed in recent randomized control trials. Thus, the ideal moisturizer type and application frequency for preventing AD development in infants remains unclear. We hypothesize that twice daily application of moisturizer is more effective than once daily application. We predict that applying sufficient amounts of high-quality moisturizer may be effective for preventing AD development in neonates and infants. Here, we describe a protocol for comparing the efficacy of twice daily and once daily application of Fam's Baby™ moisturizer and once daily application of 2e moisturizer for preventing AD in neonates.
Methods:
This study is a single-center, three-parallel group, assessor-blind, superiority, individually randomized, controlled, phase II trial. Sixty newborns with at least one parent or sibling who has had AD is randomly assigned to application of Fam's Baby twice daily, Fam's Baby once daily, or 2e once daily in a 1:1:1 ratio until 32 weeks old. The primary outcome is the time to the first onset of AD during administration of the moisturizer.
Discussion:
This is the first phase II randomized, controlled trial in Japan to estimate how effective the twice daily or once daily application of Fam's Baby moisturizer is in preventing AD compared to the once daily application of 2e moisturizer. In this study, we will use 2e once daily as a control to confirm the efficacy for primary prevention of AD as found in our previous trial. Based on the results of this study, we hope to conduct a phase III study to determine the optimal method for preventing AD via moisturizer application. Evaluation of application of moisturizers for preventing AD in this study is expected to contribute to a reduction in the prevalence of AD and a reduction in health care costs.
Trial Registration:
Japan Registry of Clinical Trials (jRCT); ID: jRCTs031200070.
More Related Videos
06:47Effects of Exposure of Formaldehyde to a Rat Model of Atopic Dermatitis Induced by Neonatal Capsaicin Treatment
Published on: September 27, 2017
04:53A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Related Concept Videos
Clinical Applications of Epidermal Stem Cells
Renewal of Skin Epidermal Stem Cells
Healthcare Associated Infections II: Preventive Measures
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...