UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037952 |
|---|---|
| Receipt number | R000043262 |
| Scientific Title | Baby Diaper Use Test |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2019/11/26 17:10:19 |
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Basic information
Public title
Baby Diaper Use Test
Acronym
Baby Diaper Use Test
Scientific Title
Baby Diaper Use Test
Scientific Title:Acronym
Baby Diaper Use Test
Region
| Asia(except Japan) |
Condition
Condition
Healthy infants
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The influential comparative analysis exerted in the skin condition in the diaper for babies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the tetter score of target part after 1 week use of several kinds of diaper for babies
Key secondary outcomes
Use questionnaire and of skin picture after 1 week use of several kinds of diaper for babies
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
After using the sample diaper P for 1 week, subjects use the regular diaper for 1 week.
Interventions/Control_2
After using the sample diaper N for 1 week, subjects use the regular diaper for 1 week
Interventions/Control_3
After using the sample diaper P for 1 week, subjects use the sample diaper K for 1 week
Interventions/Control_4
After using the sample diaper N for 1 week, subjects use the sample diaper K for 1 week
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy infants
Key exclusion criteria
1.The infant with chronic sickness.
2.The infant with the severe skin symptoms including the diaper rash.
3.The infant suffering from infectious diseases.
4.The infant who judged that the person in charge of a test in attendance is unsuitable as a test participant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Boy |
| Middle name | |
| Last name | Hendarin |
Organization
PT. INTAGE INDONESIA
Division name
Field Department
Zip code
12430
Address
Alamanda Tower 18th fl. Unit H, Jl. TB. Simatupang Kav. 23-24, Cilandak Barat, Jakarta 12430
TEL
+62-21-2966-0070
boy-hendarin@intage.com
Public contact
Name of contact person
| 1st name | Nanami |
| Middle name | |
| Last name | Watabe |
Organization
PT. INTAGE INDONESIA
Division name
Customer Service Department
Zip code
12430
Address
Alamanda Tower 18th fl. Unit H, Jl. TB. Simatupang Kav. 23-24, Cilandak Barat, Jakarta 12430
TEL
+62-21-2966-0070
Homepage URL
nanami.watabe@intage.com
Sponsor or person
Institute
PT. INTAGE INDONESIA
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9861
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
PT. INTAGE INDONESIA
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 06 | 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
59
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 | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 25 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043262
| 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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