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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039267
Receipt No. R000044782
Scientific Title A study to evaluate the effect of using tape type baby diaper
Date of disclosure of the study information 2020/01/27
Last modified on 2021/01/26

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Basic information
Public title Evaluation of the effect of using baby diaper
Acronym Evaluation of the effect of using baby diaper
Scientific Title A study to evaluate the effect of using tape type baby diaper
Scientific Title:Acronym Evaluation of the effect of using baby diaper
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Endocrinology and Metabolism Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the physiological change by using a diaper
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement physiological changes before and after using a diaper
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Using diaper A
Interventions/Control_2 Using diaper B
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
12 months-old >=
Gender Male and Female
Key inclusion criteria Healthy mothers and infants
Key exclusion criteria -Mothers and infants with systemic illness
-Mothers and infants who are taking prescription medicine
-Mothers with a palm skin disease, and are consulting with the dermatologist
-The pregnant and mothers who hope to get pregnant during the exam period
-Mothers and infants whose family members work in the company of market research, advertising, media, baby goods, sanitary goods.
-Mothers and infants deemed inappropriate to participate in this study by the principle investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Sakamoto
Organization Kao Corporation
Division name Sensory Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7682
Email sakamoto.takashi@kao.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Takashi
Organization Kao Corporation
Division name Sensory Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7682
Homepage URL
Email sakamoto.takashi@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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 27 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 20
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 01 Month 28 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 27 Day
Last modified on
2021 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044782

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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