UMIN-CTR Clinical Trial

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
Last 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
1st 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