UMIN-CTR Clinical Trial

Basic information
Public title	Baby Diaper Use Test
Acronym	Baby Diaper Use Test
Scientific Title	Baby Diaper Use Test
Scientific Title:Acronym	Baby Diaper Use Test
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	The influential comparative analysis exerted in the skin condition in the diaper for babies
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the tetter score of target part after 1 week use of several kinds of diaper for babies
Key secondary outcomes	Use questionnaire and of skin picture after 1 week use of several kinds of diaper for babies

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	After using the sample diaper P for 1 week, subjects use the regular diaper for 1 week.
Interventions/Control_2	After using the sample diaper N for 1 week, subjects use the regular diaper for 1 week
Interventions/Control_3	After using the sample diaper P for 1 week, subjects use the sample diaper K for 1 week
Interventions/Control_4	After using the sample diaper N for 1 week, subjects use the sample diaper K for 1 week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 months-old <=
Age-upper limit	36 months-old >=
Gender	Male and Female
Key inclusion criteria	Healthy infants
Key exclusion criteria	1.The infant with chronic sickness. 2.The infant with the severe skin symptoms including the diaper rash. 3.The infant suffering from infectious diseases. 4.The infant who judged that the person in charge of a test in attendance is unsuitable as a test participant.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Boy Middle name Last name Hendarin
Organization	PT. INTAGE INDONESIA
Division name	Field Department
Zip code	12430
Address	Alamanda Tower 18th fl. Unit H, Jl. TB. Simatupang Kav. 23-24, Cilandak Barat, Jakarta 12430
TEL	+62-21-2966-0070
Email	boy-hendarin@intage.com

Public contact
Name of contact person	1st name Nanami Middle name Last name Watabe
Organization	PT. INTAGE INDONESIA
Division name	Customer Service Department
Zip code	12430
Address	Alamanda Tower 18th fl. Unit H, Jl. TB. Simatupang Kav. 23-24, Cilandak Barat, Jakarta 12430
TEL	+62-21-2966-0070
Homepage URL
Email	nanami.watabe@intage.com

Sponsor
Institute	PT. INTAGE INDONESIA
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	+81-3-5630-9861
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	PT. INTAGE INDONESIA

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 06 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	59
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 07 Month 25 Day
Date of IRB	2019 Year 07 Month 25 Day
Anticipated trial start date	2019 Year 09 Month 10 Day
Last follow-up date	2019 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 06 Day
Last modified on	2019 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043262