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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038138
Receipt No. R000043469
Scientific Title Fact-finding survey of baby skin (V02)
Date of disclosure of the study information 2019/10/18
Last modified on 2020/03/31

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Basic information
Public title Fact-finding survey of baby skin (V02)
Acronym Fact-finding survey of baby skin (V02)
Scientific Title Fact-finding survey of baby skin (V02)
Scientific Title:Acronym Fact-finding survey of baby skin (V02)
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 To obtain the knowledge about skin characteristics of baby skin.
Basic objectives2 Others
Basic objectives -Others Dermatological assessment in diaper area
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dermatological assessment in diaper area
Key secondary outcomes

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
3 months-old <=
Age-upper limit
24 months-old >=
Gender Male and Female
Key inclusion criteria Healthy baby
Key exclusion criteria 1. Skin trouble which is caused by systemic allergy (e.g. food allergy, cow milk allergy, etc.).
2. Babies with atopic dermatitis.
3. Presence of systemic illness.
4. Babies under-medication for their skin troubles.
5. Babies with diarrhea during screening.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Haruko
Middle name
Last name Toyoshima
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7781
Email toyoshima.haruko@kao.com

Public contact
Name of contact person
1st name Rinko
Middle name
Last name Takagi
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7781
Homepage URL
Email takagi.rinko@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 Toyo Science Corp.
SMART Research Corp.
Children Hospital 2
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 +81-3-5630-7263
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 Children Hospital 2(Ho Chi Minh City, Vietnam)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 18 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 Completed
Date of protocol fixation
2019 Year 09 Month 30 Day
Date of IRB
2019 Year 09 Month 30 Day
Anticipated trial start date
2019 Year 10 Month 18 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To obtain the knowledge about skin characteristics of baby skin.

Management information
Registered date
2019 Year 09 Month 27 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=R000043469

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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