UMIN-CTR Clinical Trial

Basic information
Public title	A follow-up study to evaluate the infant skin condition in summer
Acronym	A study to evaluate the infant skin condition
Scientific Title	A follow-up study to evaluate the infant skin condition in summer
Scientific Title:Acronym	A study to evaluate the infant skin condition
Region	Japan

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

Objectives
Narrative objectives1	Understandings of skin condition
Basic objectives2	Others
Basic objectives -Others	Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement of infant skin condition
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	12 months-old <=
Age-upper limit	24 months-old >=
Gender	Male and Female
Key inclusion criteria	Healthy infants
Key exclusion criteria	1. Infant with chronic sickness. 2. Infant with the severe skin symptoms who needs treatment of an atopic dermatitis et al. 3. The infant infected with a disease of infectibility disease. 4. The infant who judged that a test doctor in attendance was unsuitable as a test participant.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Okuda
Organization	Kao Corporation
Division name	R&D - Development Research - Sanitary Products Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7432
Email	okuda.yasuyuki@kao.co.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Kajiwara
Organization	Kao Corporation
Division name	R&D - Development Research - Sanitary Products Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7379
Homepage URL
Email	kajiwara.jun@kao.co.jp

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	+81-3-5630-9220
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	DRC株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 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	2017 Year 07 Month 10 Day
Date of IRB	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 18 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 01 Month 19 Day

Other
Other related information	Measurement of infant skin condition

Management information
Registered date	2017 Year 07 Month 19 Day
Last modified on	2021 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032372