UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021713 |
|---|---|
| Receipt number | R000025048 |
| Scientific Title | Skin survey of elderly people |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2016/03/31 16:10:08 |
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Basic information
Public title
Skin survey of elderly people
Acronym
Skin survey of elderly people
Scientific Title
Skin survey of elderly people
Scientific Title:Acronym
Skin survey of elderly people
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate changes of skin function due to aging widely, we screen the persons of lower and higher physical function level in QOL score and compare the skin function in each group.
Basic objectives2
Others
Basic objectives -Others
Observational study to know the skin properties of the elderly person.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
skin appearance and obsevation
Key secondary outcomes
skin moisture content,percutaneous water transpiration quantity,skin temperature,skin elasticity,skin pH
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
| 65 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and female between 65 and 89 years old who lives in the Tokyo metropolitan region and recruited in mail or web by SOUKEN Co., Ltd.
2.Higher and lower group (top 20(1/4) and bottom 20(1/4) persons) of physical function level with description type QOL evaluation method SF36 in each coevals.
3.A person who is possible to walk independently.
4.A person with consent for study and able to participate in inspection schedule.
Key exclusion criteria
1.A person who has serious disease (heart disease, renal disease, diabetes) and is difficult to live a daily life (without person who controls symptoms by medicine dosing and so on, and has no problems in daily life).
2.A person who is impossible to walk independently.
3.A person with dementia.
4.A person who is judged inappropriate to join the study by management doctor or person in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Maruya |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
http://www.souken-lab.co.jp/
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Kao corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | 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
Observational study
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
