UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032798 |
|---|---|
| Receipt number | 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 09:42:05 |
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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
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
dermayuan@163.com
Sponsor or person
Institute
Shanghai Skin Diseases Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037416
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
