UMIN-CTR Clinical Trial

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

atopic dermatitis, allergic sensitization

Classification by specialty

Clinical immunology	Pediatrics	Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

National Center for Child Health & Development

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

11

Month

11

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2010

Year

11

Month

11

Day

Last modified on

2014

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005429