UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the effect after using diaper XI
Acronym	A study to evaluate the effect after using diaper XI
Scientific Title	A study to evaluate the effect after using diaper XI
Scientific Title:Acronym	A study to evaluate the effect after using diaper XI
Region	Japan

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

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

Assessment
Primary outcomes	Skin condition before the use of test diaper, after 1 weeks, after 2 weeks and 2 weeks after returning to favorite diaper.
Key secondary outcomes	Skin microflora before the use of test diaper, after 1 weeks, after 2 weeks and 2 weeks after returning to favorite diaper. Ingredient of sebum before the use of test diaper, after 1 weeks and after 2 weeks.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Use the test diaper for 14 days, following the favorite diaper for 14 days.
Interventions/Control_2	Use the control diaper for 14 days, following the favorite diaper for 14 days.
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	8 months-old >=
Gender	Male and Female
Key inclusion criteria	1. 3-8 months old (less than 7.5kg) Japanese infants who lives in or near Tokyo. 2. Infants who use tape-type s size diaper all day. 3. Infants whose parents admit that they are worried about diaper dermatitis.
Key exclusion criteria	1. Infants who are under medical treatment or on medication for skin trouble. 2. Infants who were diagnosed with any disease among chronic disease and congenital disorder. 3. Infants who were affected with infectious disorder from one month before the start of the test to the start of the test. 4. Infants who used antibiotics, steroids, or medicated cleaning agents from one month before the start of the test to the start of the test.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Fukuda
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	0285-68-7597
Email	fukuda.yuuko1@kao.com

Public contact
Name of contact person	1st name Sanae Middle name Last name Sagara
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	0285-68-7285
Homepage URL
Email	sagara.sanae@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
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	株式会社SOUKEN（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 21 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	Preinitiation
Date of protocol fixation	2022 Year 01 Month 17 Day
Date of IRB	2022 Year 01 Month 17 Day
Anticipated trial start date	2022 Year 01 Month 20 Day
Last follow-up date	2022 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 21 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053259

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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