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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034179
Receipt No. R000038911
Scientific Title A study to evaluate the effect after using baby diaper III
Date of disclosure of the study information 2018/09/21
Last modified on 2019/03/04

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Basic information
Public title A study to evaluate the effect after using baby diaper III
Acronym A study to evaluate the effect after using baby diaper III
Scientific Title A study to evaluate the effect after using baby diaper III
Scientific Title:Acronym A study to evaluate the effect after using baby diaper III
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 Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Diaper(J) or Diaper(S) (2weeks)-> Diaper(T) (2weeks)
Interventions/Control_2 Diaper(T) (2weeks)-> Diaper(J) or Diaper(S) (2weeks)
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
24 months-old >=
Gender Male and Female
Key inclusion criteria Healthy baby
Key exclusion criteria 1.Babiess who have a skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, critical ermatitis).
2.Babies who have chronic illness and congenital illness and systemic illness.
3.Babies who have applied going to hospital regularly, a therapy or medication, and medicine in the skin trouble.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoshima Haruko
Organization Kao Corporation
Division name R&D -Development Research- Sanitary Products Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7448
Email toyoshima.haruko@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Rinko Takagi
Organization Kao Corporation
Division name R&D -Development Research- Sanitary Products Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7448
Homepage URL
Email takagi.rinko@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 Queen Sirikit National Institute of Child Health
Dermscan Asia
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 Queen Sirikit National Institute of Child Health(タイ)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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 Completed
Date of protocol fixation
2018 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038911

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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