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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038153
Receipt No. R000043492
Scientific Title A Study on the association with allergen, a stimulant and skin condition of babies.
Date of disclosure of the study information 2019/10/09
Last modified on 2020/03/31

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Basic information
Public title A Study on the association with allergen, a stimulant and skin condition of babies.
Acronym A Study on the association with allergen, a stimulant and skin condition of babies.
Scientific Title A Study on the association with allergen, a stimulant and skin condition of babies.
Scientific Title:Acronym A Study on the association with allergen, a stimulant and skin condition of babies.
Region
Japan

Condition
Condition Healthy babys
Classification by specialty
Pediatrics Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verify the association with allergen, a stimulant and skin condition of babies.
Basic objectives2 Others
Basic objectives -Others Survey on actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Association with allergens and other stimulants and skin condition
Key secondary outcomes -Total weight, classification and ingredient analysis of allergens and other stimulants
-Association with questionnaire items and skin condition
-Association with questionnaire items and allergens and other stimulants

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
10 months-old <=
Age-upper limit
14 months-old >=
Gender Male and Female
Key inclusion criteria - The babies who use a paper diaper
- The babies who go to bed with futon for adults
Key exclusion criteria - The baby having a serious disease to need treatment
- The baby who is infected with an infectious disease
- The baby who have loose bowels on a day to perform the diagnosis by the doctor and skin observation or is easy to have loose bowels routinely
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Tojo
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code 1318501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL +81-3-5630-9557
Email tojo.kaori@kao.com

Public contact
Name of contact person
1st name Noriko
Middle name
Last name Haketa
Organization Kao Corporation
Division name Skin Care Products Research Laboratory
Zip code 1318501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL +81-3-5630-7286
Homepage URL
Email haketa.noriko@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9861
Email morisaki.naoko@kao.com

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 株式会社インフォワード(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 08 Month 05 Day
Date of IRB
2019 Year 08 Month 05 Day
Anticipated trial start date
2019 Year 10 Month 09 Day
Last follow-up date
2019 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Verify the association with allergen, a stimulant and skin condition of babies.

Management information
Registered date
2019 Year 09 Month 30 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043492

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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