UMIN-CTR Clinical Trial

Public title

Birth Cohort Observational Study of Factors Associated with the Development of Infant Atopic Dermatitis

Acronym

Study of factors associated with the development of infantile atopic dermatitis

Scientific Title

Birth Cohort Observational Study of Factors Associated with the Development of Infant Atopic Dermatitis

Scientific Title:Acronym

Study of factors associated with the development of infantile atopic dermatitis

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Pediatrics	Dermatology	Child

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Barrier dysfunction associated with atopic dermatitis (AD) in the infancy is one of most important factors for food allergen sensitization and food allergy (FA). It was reported that some moisturizing agents reduced incidence of AD in infancy. However, its effect may not be sufficient. The aim of this study is to elucidate factors related with AD in infancy by comparing the children who develop AD and those who do not develop AD despite of cleaning and moisturization to keep barrier function from neonatal period until 12 months of age.
Transepidermal water loss, immunoactive substances in sera and breast milk, bacterial flora of skin, feces and saliva are examined at several time points from birth until 12 months of age.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

prevalence late of atopic dermatitis in 12 months

Key secondary outcomes

(1)Allergen sensitisation
(2)Skin condition
(3)Saliva, skin, and fecal flora
(4)Immunoreactive substances in breast milk and sera

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Healthy full-term newborns
(2)Those who have agreed to participate in the study by their parents and guardians

Key exclusion criteria

(1)Premature and low birth weight infants
(2)Infants scheduled for a recent relocation and not scheduled for an infant health checkup at the study site
(3)Infants with a family history of hereditary skin disorders (excluding ichthyosis vulgaris)

Target sample size

200

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Shimojo

Organization

Graduate School of Medicine, Chiba University

Division name

Department of pediatrics

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba, JAPAN

TEL

043-226-2144

Email

shimojo@faculty.chiba-u.jp

Name of contact person

1st name	Naoki
Middle name
Last name	Shimojo

Organization

Graduate School of Medicine, Chiba University

Division name

Department of pediatrics

Zip code

260-8670

Address

1-8-1 Inohana, Chuo-ku, Chiba, JAPAN

TEL

043-226-2144

Homepage URL

Email

shimojo@faculty.chiba-u.jp

Institute

Graduate School of Medicine, Chiba University

Institute

Department

Personal name

Organization

AMED
Chiba University
Miraka Co.Ltd

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

(1)Ichikawa clinic
(2)University of Michigan,Michigan Medicine
(3)Miraca Research Institute G.K.
(4)Nagoya University Graduate School of Medicine, Department of Dermatology
(5)Natural Science Co.,Ltd.

Name of secondary funder(s)

Organization

Graduate School of Medicine, Chiba University

Address

1-8-1 Inohana Chuo-ku Chba city, Japan

Tel

043-226-2144

Email

shimojo@faculty.chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人いちかわクリニック（福島県）

Date of disclosure of the study information

2018

Year

09

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

No longer recruiting

Date of protocol fixation

2018

Year

03

Month

23

Day

Date of IRB

2018

Year

03

Month

23

Day

Anticipated trial start date

2019

Year

02

Month

16

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(1)Investigate the incidence of atopic dermatitis up to 12 months of age in infants whose skin care was done by washing and moisturizing, and compare past data (historical control).
(2)About the cohort of (1)above, development of AD, allergen sensitization, the bacterial flora of saliva/skin/stool, immunoactive substance in breast milk and sera will be evaluated.Based on these studies factors on the maternal side and infant side related to development of AD and sensitization will be found and used for future prevention of allergic diseases.

Registered date

2018

Year

07

Month

16

Day

Last modified on

2025

Year

01

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037568