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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032798
Receipt No. R000037416
Scientific Title BABY DIAPER STUDY (No.2016-001)
Date of disclosure of the study information 2018/05/31
Last modified on 2018/05/31

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Basic information
Public title BABY DIAPER STUDY (No.2016-001)
Acronym BABY DIAPER STUDY (No.2016-001)
Scientific Title BABY DIAPER STUDY (No.2016-001)
Scientific Title:Acronym BABY DIAPER STUDY (No.2016-001)
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 Safety,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 YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Diaper(H) (2weeks)-> Diaper(T) (2weeks)
Interventions/Control_2 Diaper(T) (2weeks)-> Diaper(H) (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.Babies with atopic dermatitis
2.Presence of systemic illness
3.Babies in treatment for their skin troubles
4.Babies who experience diarrhea during screening
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuan Chao
Organization Shanghai Skin Diseases Hospital
Division name Skin & Cosmetic Research Department
Zip code
Address 1278 Bao De Road, Zha Bei Distrct, Shanghai, 200443, China
TEL +86-21-61833059
Email dermayuan@163.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuan Chao
Organization Shanghai Skin Diseases Hospital
Division name Skin & Cosmetic Research Department
Zip code
Address 1278 Bao De Road, Zha Bei Distrct, Shanghai, 200443, China
TEL +86-21-61833059
Homepage URL
Email dermayuan@163.com

Sponsor
Institute Shanghai Skin Diseases Hospital
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
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 上海市皮膚病医院(中国上海市)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.hindawi.com/journals/bmri/aip/5874184/
Number of participants that the trial has enrolled
Results The new material diaper is superior to the standard diaper for the prevention of diaper rash in Chinese babies.
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
2016 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 23 Day
Last follow-up date
2016 Year 07 Month 26 Day
Date of closure to data entry
2017 Year 03 Month 10 Day
Date trial data considered complete
2017 Year 03 Month 10 Day
Date analysis concluded
2018 Year 05 Month 13 Day

Other
Other related information

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037416

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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