UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036205 |
|---|---|
| Receipt number | R000041244 |
| Scientific Title | Fact-finding survey of baby skin I |
| Date of disclosure of the study information | 2019/04/04 |
| Last modified on | 2021/10/12 22:46:56 |
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Basic information
Public title
Fact-finding survey of baby skin I
Acronym
Fact-finding survey of baby skin I
Scientific Title
Fact-finding survey of baby skin I
Scientific Title:Acronym
Fact-finding survey of baby skin I
Region
| Asia(except Japan) |
Condition
Condition
Healthy baby
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain the knowledge about skin characteristics of baby skin.
Basic objectives2
Others
Basic objectives -Others
Analyze of skin constituent on diaper area.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of constituent on skin.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. 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
4. Baby who experiences diarrhea during screening
Target sample size
60
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
0285-68-7844
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
0285-68-7844
Homepage URL
hayashi.kazuhiko@kao.com
Sponsor or person
Institute
Kao Corporation
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
Toyo Science Corp.
PT Equilab International
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
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
PT Equilab International
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 04 | 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
63
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 | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analyze of skin constituent on diaper area.
Management information
Registered date
| 2019 | Year | 03 | Month | 15 | Day |
Last modified on
| 2021 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041244
| 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 |
