UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 10 Month 12 Day

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