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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021713
Receipt No. R000025048
Scientific Title Skin survey of elderly people
Date of disclosure of the study information 2016/03/31
Last modified on 2016/03/31

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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
Email 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/
Email jimukyoku@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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