UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect after using baby diaperIX
Acronym	A study to evaluate the effect after using baby diaperIX
Scientific Title	A study to evaluate the effect after using baby diaperIX
Scientific Title:Acronym	A study to evaluate the effect after using baby diaperIX
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	To evaluate the effect after using baby diaper
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dermatological assessment before and after using diaper for 2, 4 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Sample(H) (2weeks)->Sample(J) (2weeks)
Interventions/Control_2	Sample(J) (2weeks)->Sample(H) (2weeks)
Interventions/Control_3	Sample(T) (2weeks)->Sample(S) (2weeks)
Interventions/Control_4	Sample(S) (2weeks)->Sample(T) (2weeks)
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 infant
Key exclusion criteria	1.Infant with skin disease 2.Infant with atopic dermatitis. 3.Infant diagnosed with chronic disease or congenital disorder. 4.Infant under-medication for their skin troubles. 5.Infant with diarrhea at screening.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Fukuda
Organization	Kao Corporation
Division name	Sanitary Products Research
Zip code	321-3497
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7597
Email	fukuda.yuuko1@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	0285-68-7913
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. 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	+81-3-5630-9220
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(Vietnam)

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 26 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	119
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	2020 Year 01 Month 22 Day
Date of IRB	2020 Year 01 Month 22 Day
Anticipated trial start date	2020 Year 07 Month 20 Day
Last follow-up date	2020 Year 09 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 07 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 24 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046678