UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to evaluate the dermatological skin condition of babies (T01)
Title of the study (Brief title)	Study to evaluate the dermatological skin condition of babies (T01)
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	To know the dermatological skin condition in diaper area of babies
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	Not applicable
Age-upper limit	2 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy baby
Key exclusion criteria	1.Babiess who have a skin trouble caused by allergy 2.Babiess who have atopic dermatitis 3.Babies who have trouble with their illness to the whole body 4.Babies who have applied medicine in the skin trouble 5.Babies who experience diarrhea
Target sample size	160

Research contact person
Name of lead principal investigator	Toyoshima Haruko
Organization	Kao Corporation
Division name	R&D -Development Research- Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7448
Email	toyoshima.haruko@kao.com

Public contact
Name of contact person	Rinko Takagi
Organization	Kao Corporation
Division name	R&D -Development Research- Sanitary Products Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7448
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	Taipei Medical University MITHRA BIOTECHNOLOGY
Name of secondary funｄer(s)

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	Taipei Medical University（台湾）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 05 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To know the dermatological skin condition in diaper area of babies

Management information
Registered date	2018 Year 04 Month 25 Day
Last modified on	2018 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036749