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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032852
Receipt No. R000037367
Scientific Title Effect of Hand Antisepsis on Skin Protection
Date of disclosure of the study information 2018/06/03
Last modified on 2018/12/04

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Basic information
Public title Effect of Hand Antisepsis on Skin Protection
Acronym Effect of Hand Antisepsis on Skin Protection
Scientific Title Effect of Hand Antisepsis on Skin Protection
Scientific Title:Acronym Effect of Hand Antisepsis on Skin Protection
Region
Japan

Condition
Condition N/A (healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effect of hand antisepsis on skin protection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Indexes for skin protection (skin viscoelasticity, moisture content [before application, 5th time after application, 10th time after application)
Key secondary outcomes [1]Feeling questionnaire (10th time after application)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 9
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Application of test product A (10 times).
Interventions/Control_2 Application of test product B (10 times).
Interventions/Control_3 Application of test product C (10 times).
Interventions/Control_4 Application of control product A (10 times).
Interventions/Control_5 Application of control product B (10 times).
Interventions/Control_6 Application of control product C (10 times).
Interventions/Control_7 Application of control product D (10 times).
Interventions/Control_8 Application of control product E (10 times).
Interventions/Control_9 No application (10 times).
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria [1]Males or females aged 20-64 years.
[2]Nurse and laboratory technician who works at a hospital with an Infection Control Committee and an Infection Control Nurse.
[3]Nurse and laboratory technician who uses hand antisepsis daily.
[4]Nurse and laboratory technician whose written informed consent has been obtained.
[5]Nurse and laboratory technician who can have an examination in a designated day.
[6]Nurse and laboratory technician judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals with strange skin conditions at measurement points.
[3]Individuals with a scar, an inflammation, eczema, and sunburn on measurement points (inside of the arm and palm).
[4]Individuals who are sensitive to alcohol.
[5]Individuals with probable skin disease such as itching, rubefaction, and eczema.
[6]Individuals who are or are possibly, or are lactating.
[7]Individuals judged inappropriate for the study by the principal.
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shuji Nakata
Organization Medical Corporation Bokushinkai CLINTEXE Clinic
Division name Head
Zip code
Address 4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL +81-3-5405-1059
Email info@tes-h.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization GOJO Japan, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2018 Year 06 Month 03 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
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
2018 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 03 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037367

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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