UMIN-CTR Clinical Trial

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