UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Hand Antisepsis on Skin Protection
Title of the study (Brief title)	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
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Head
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
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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