UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036406 |
|---|---|
| Receipt number | R000041439 |
| Scientific Title | The influence that everyday skin care or dietary habits from time give in the measurement data using the onset of the skin disease and the Corner layer fluid volume measuring instrument since childhood. |
| Date of disclosure of the study information | 2019/04/04 |
| Last modified on | 2019/04/04 10:22:02 |
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Basic information
Public title
The influence that everyday skin care or dietary habits from time give in the measurement data using the onset of the skin disease and the Corner layer fluid volume measuring instrument since childhood.
Acronym
Skin examination
Scientific Title
The influence that everyday skin care or dietary habits from time give in the measurement data using the onset of the skin disease and the Corner layer fluid volume measuring instrument since childhood.
Scientific Title:Acronym
Skin examination
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influences of the lifestyle (skin care habits, exposure situation of sunlight) from childhood until now on onset of skin diseases and moisture level of skin stratum corneum.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire about the lifestyle (skin care habits, exposure situation of sunlight) from childhood until now.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Person belong to Wayo Women's University with written consent of the participation after received explanation in writing about the study.
Key exclusion criteria
None
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Tekehiko |
| Middle name | |
| Last name | Kaneko |
Organization
Wayo Women's University
Division name
Vice president
Zip code
272-0827
Address
2-3-1, kokubudai, ichikawa-shi, Chiba, 272-0827, Japan
TEL
047-371-1111
t-kaneko@wayo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Ogaki |
Organization
EBC&M LLC.
Division name
Clinical Business Department
Zip code
105-0011
Address
2-9-1, shibakoen, minato-ku, Tokyo, 105-0011, Japan
TEL
03-6435-3833
Homepage URL
yoshitaka_ogaki@ebc-m.com
Sponsor or person
Institute
Non-profit Organization, Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
POLA Pharma INC.
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
Wayo Women's University
Address
2-3-1, kokubudai, ichikawa-shi, Chiba, 272-0827, Japan
Tel
047-371-1111
t-kaneko@wayo.ac.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
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
225
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
| 2018 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 17 | Day |
Other
Other related information
The practice situation of the skin care from the young children period to date, a lot of customs of the meal intake decided to perform a study of searching what kind of influence the onset of an allergic disease and the skin disease had on the objective index indicating the skin state including the keratin fluid volume more. Specifically, I planned enforcement of the questionary survey about examination, an investigation into health condition of the skin by the dermatologist and a past lifestyle for female college students.
Management information
Registered date
| 2019 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041439
| 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 |
