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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028881
Receipt No. 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

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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
Email 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
Email yoshitaka_ogaki@ebc-m.com

Sponsor
Institute Non-Profit Organization Health Institute
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033053

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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