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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037251
Receipt No. R000042477
Scientific Title A study to evaluate the effect after using diaper VIII
Date of disclosure of the study information 2019/07/22
Last modified on 2020/01/06

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Basic information
Public title A study to evaluate the effect after using diaper VIII
Acronym A study to evaluate the effect after using diaper VIII
Scientific Title A study to evaluate the effect after using diaper VIII
Scientific Title:Acronym A study to evaluate the effect after using diaper VIII
Region
Asia(except 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 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 -participants 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(S) (2weeks)
Interventions/Control_2 Sample(T) (2weeks)=>Sample(J) (2weeks)
Interventions/Control_3 Sample(S) (2weeks)=>Sample(H) (2weeks)
Interventions/Control_4 Sample(J) (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 baby
Key exclusion criteria 1. Baby with skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, serious dermatitis)
2. Baby with any disease among chronic disease, congenital disorder and infections disorder.
3. Baby under medical treatment or on medication for skin trouble
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Haruko
Middle name
Last name Toyoshima
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7781
Email toyoshima.haruko@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 0285-68-7781
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 Mithra Biotechnology
Taipei Medical University
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 uesaka.toshio@kao.co.jp

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

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 22 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 97
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 04 Month 10 Day
Date of IRB
2019 Year 04 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 22 Day
Last follow-up date
2019 Year 10 Month 27 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 07 Month 03 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042477

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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