UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049520 |
|---|---|
| Receipt number | R000056393 |
| Scientific Title | Survey on toddlers' lives, activities, and skin surface components |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2022/11/16 09:29:10 |
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Basic information
Public title
Survey on toddlers' lives, activities, and skin surface components
Acronym
Survey on toddlers' lives, activities, and skin surface components
Scientific Title
Survey on toddlers' lives, activities, and skin surface components
Scientific Title:Acronym
Survey on toddlers' lives, activities, and skin surface components
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Survey on the Relationship between toddlers' Activities and Growth
Evaluation of motor skill and mental strength by analyzing skin surface components of three-year-old toddlers
Basic objectives2
Others
Basic objectives -Others
To study on the relationship between the activities and growth of toddlers in Japan, and to Compare with existing Chinese data.
To identify the relationship of skin condition with motor skill and mental strength.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of the relationship between activity and growth of toddlers in Japan, and international comparison between Japan and China.
Evaluation of motor skilland mental strength by analyzing skin surface components of three-year-old toddlers
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
| 36 | months-old | <= |
Age-upper limit
| 39 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female toddlers (36 months to 38 months old), and their mothers
2. Toddlers and their mothers living in Japan from birth to the present
3. Toddlers and their mothers who can come to the designated test site on the designated day
4. Mothers who can agree to answer questions such as height, weight, educational background, annual income, medical history, disability, size of residence, and medical history of the target toddler's parents
Key exclusion criteria
1. During the two weeks before going to the test site, the toddler or mother have a fever or respiratory symptoms.
2. During the two weeks before going to the test site, the family living with the toddler and mother have a fever or respiratory symptoms.
3. Toddlers had dermatitis on the face and doctor gave them guidance (used of oral medicine, external medicine, moisturizing agent) for treating the symptoms.
4. Although without doctor's judge, mother judged that the toddler couldn't stop using skin care medicines.
5. Subjects deemed inappropriate to participate in this study by the research staff
Target sample size
324
Research contact person
Name of lead principal investigator
| 1st name | Yuuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Products Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7531
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Yuuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Products Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7531
Homepage URL
fukuda.yuuko1@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
Juntendo University
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
+81-3-5630-9064
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To study on the relationship between the activities and growth of toddlers in Japan, and to Compare with existing Chinese data.
To identify the relationship of skin condition with motor skill and mental strength.
Management information
Registered date
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056393
