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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036205
Receipt No. R000041244
Scientific Title Fact-finding survey of baby skin I
Date of disclosure of the study information 2019/04/04
Last modified on 2019/09/13

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Basic information
Public title Fact-finding survey of baby skin I
Acronym Fact-finding survey of baby skin I
Scientific Title Fact-finding survey of baby skin I
Scientific Title:Acronym Fact-finding survey of baby skin I
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 Analyze of skin constituent on diaper area.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of constituent on skin.
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. Baby with skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, serious dermatitis)
2. Baby with any disease among chronic disease, congenital disorder and infections disorder.
3. Baby under medical treatment or on medication for skin trouble
4. Baby who experiences diarrhea during screening
Target sample size 60

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 0285-68-7844
Email toyoshima.haruko@kao.com

Public contact
Name of contact person
1st name Kazuhiko
Middle name
Last name Hayashi
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7844
Homepage URL
Email hayashi.kazuhiko@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.
PT Equilab International
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 +81-3-5630-9220
Email uesaka.toshio@kao.co.jp

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 PT Equilab International

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 04 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 63
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 03 Month 01 Day
Date of IRB
2019 Year 03 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 04 Day
Last follow-up date
2019 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyze of skin constituent on diaper area.

Management information
Registered date
2019 Year 03 Month 15 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041244

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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