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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004544
Receipt No. R000005429
Scientific Title Effect of emollients on the prevention of infantile eczema and atopic dermatitis
Date of disclosure of the study information 2010/11/11
Last modified on 2014/10/02

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Basic information
Public title Effect of emollients on the prevention of infantile eczema and atopic dermatitis
Acronym Effect of emollients on the prevention of atopic dermatitis
Scientific Title Effect of emollients on the prevention of infantile eczema and atopic dermatitis
Scientific Title:Acronym Effect of emollients on the prevention of atopic dermatitis
Region
Japan

Condition
Condition atopic dermatitis, allergic sensitization
Classification by specialty
Clinical immunology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our hypothesis is that skin barrier protection from early in life using emollients is a safe and effective strategy for prevention of atopic dermatitis and allergic sensitization.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The original description in the English version was incorrectly translated. The original description of primary outcome measure in Japanese (the left column) should have been translated as "cumulative rate of incidence of atopic dermatitis and/or eczema by temporal observation".
Key secondary outcomes a) specific IgE antibodies
b) transepidermal water loss(TEWL)
c) stratum corneum water concentration
d) stratum corneum pH
e) Staphylococcus aureus on skin
f) Onset of allergic diseases such as asthma and food allergy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Proactive treatment with emollients (emollient is regularly applied to the whole surface of baby's skin at least once a day)
Interventions/Control_2 Reactive treatment with emollients (emollient is used only when the parents consider the baby's skin dry)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
0 weeks-old <=
Age-upper limit
1 weeks-old >=
Gender Male and Female
Key inclusion criteria (1) Infants within the first week after birth
(2) High risk infants from atopic dermatitis (family history)
(3) Infants without treatment with corticosteroids
(4) Infants whose parents gave informed consent
Key exclusion criteria (1) Infants treated with corticosteroid ointment (except genital and anal area)
(2) Infants with skin lesions such as dyskeratosis or bullosis diagnosed by specialists in dermatology
(3) Small-for-gestational-age (<37 weeks)
(4) Infants with hepatic disease, convulsion, cardiac disease, hemophilias, diabetes and auto immune diseases
(5) Inappropriate cases evaluated by doctors
Target sample size 216

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saito Hirohisa
Organization National Research Institute for Child Health & Development
Division name Deputy Director
Zip code
Address 2-10-1 , Okura , Setagaya , Tokyo, Japan
TEL 03-3416-0181
Email saito-hr@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Horimukai
Organization National Research Institute for Child Health & Development
Division name Department of Allergy
Zip code
Address 2-10-1 Okura
TEL 03-3416-0181
Homepage URL
Email horimukai-k@ncchd.go.jp

Sponsor
Institute National Center for Child Health & Development
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jacionline.org/home
Number of participants that the trial has enrolled
Results
Background: Recent studies have suggested that epidermal barrier dysfunction contributes to the development of atopic dermatitis (AD) and other allergic diseases.
Objective: We performed a prospective, randomized controlled trial to investigate whether protecting the skin barrier with a moisturizer during the neonatal period prevents development of AD and allergic sensitization.
Methods: An emulsion-type moisturizer was  applied daily during the first 32 weeks of life to 59 out of 118 neonates at high risk for AD (based on having a parent or sibling with AD) who were enrolled in this study.  The onset of AD (eczematous symptoms lasting more than 4 weeks) and eczema (lasting more than 2 weeks) were assessed by a dermatology specialist, based on the modified Hanifin and Rajka criteria. The primary outcome was the cumulative incidence of AD plus eczema (AD/eczema) at week 32 of life. A secondary outcome, allergic sensitization, was evaluated based on serum levels of allergen-specific IgE, determined using a novel allergen microarray of diamond-like carbon-coated chip.
Results: Approximately 32% fewer neonates who received the moisturizer developed AD/eczema by week 32 than controls (P=.012 in log-rank test). Although similar proportions of infants in each group developed allergies, the rate of allergic sensitization was significantly higher in infants who developed AD/eczema than in those who did not (based on level of antibody against egg white, 0.34 kUA/L CAP-FEIA equivalents; odds ratio, 2.86; 95% confidence interval, 1.22-6.73).
Conclusion: Daily application of moisturizer during the first 32 weeks of life  reduces the risk of AD/eczema in infants. Allergic sensitization during this time period is associated with the presence of eczematous skin, but not with moisturizer use.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2010 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2013 Year 11 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The title:
Application of moisturizer to neonates prevents development of atopic dermatitis
Authors:
Kenta Horimukai, Kumiko Morita, Masami Narita, Mai Kondo, Hiroshi Kitazawa, Makoto Nozaki, Yukiko Shigematsu, Kazue Yoshida, Hironori Niizeki, Ken-ichiro Motomura, Haruhiko Sago, Tetsuya Takimoto, Eisuke Inoue, Norio Kamemura, Hiroshi Kido, Junzo Hisatsune, Motoyuki Sugai, Hiroyuki Murota, Ichiro Katayama, Takashi Sasaki, Masayuki Amagai, Hideaki Morita, Akio Matsuda, Kenji Matsumoto, Hirohisa Saito, Yukihiro Ohya
The Journal:
J Allergy Clin Immunol 2014;134:824-30.

Management information
Registered date
2010 Year 11 Month 11 Day
Last modified on
2014 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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