UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028881 |
|---|---|
| Receipt number | R000033053 |
| Scientific Title | A study on the effectiveness of skin-care education for the staff in the elderly facilities on the skin condition of residents |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2019/03/29 13:00:19 |
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Basic information
Public title
A study on the effectiveness of skin-care education for the staff in the elderly facilities on the skin condition of residents
Acronym
A study on the effectiveness of skin-care education for the staff in the elderly facilities on the skin condition of residents
Scientific Title
A study on the effectiveness of skin-care education for the staff in the elderly facilities on the skin condition of residents
Scientific Title:Acronym
A study on the effectiveness of skin-care education for the staff in the elderly facilities on the skin condition of residents
Region
| Japan |
Condition
Condition
asteatosis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of the change in the consciousness and behavior of the staff of the elderly person who took the skin-care education training on the skin condition of residents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of skin dryness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
skin-care education
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Residents in research institutes
2) Patients who were not expected to undergo major changes in the general condition during the research period
3) Patients with asteatosis on the lower leg
4) Patients who provided written informed consent after receiving an explanation of the details of the study
Key exclusion criteria
1) Patients with extensive skin diseases (burns, psoriasis etc.) (asteatosis are excepted)
2) Patients with inflammatory skin disease on the lower leg
3) Patients who had history of allergy to various external moisturizer
4) Patients who had participated in other clinical researches or clinical trials within 4 months before the start of the study
5) Patients who were considered inappropriate for the study by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Tsunemi |
Organization
Tokyo Woman's Medical University
Division name
Department of Dermatology
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjyuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
ytsun-tky@umin.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
ShibaMatsuo Building 4F, 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
Institute
Department
Personal name
Funding Source
Organization
Maruho Co., Ltd.
Medical Affairs Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Benesse Style Care Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Shinkokai
Address
Hakuaido Building 3F, 1-18-7, NishiShinjyuku, Shinjyuku-ku, Tokyo, Japan
Tel
0353547388
kawabata@hifuka.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
| 2017 | Year | 08 | 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
28
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
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 19 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033053
| 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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