UMIN-CTR Clinical Trial

Basic information
Public title	Verification of Hand Antisepsis and Its Feeling.
Acronym	Verification of Hand Antisepsis and Its Feeling.
Scientific Title	Verification of Hand Antisepsis and Its Feeling.
Scientific Title:Acronym	Verification of Hand Antisepsis and Its Feeling.
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 verify of hand antisepsis and its feeling.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Feeling questionnaire (1st time and 10th time after application).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Application of test product (10 times).
Interventions/Control_2	Application of control product A (10 times).
Interventions/Control_3	Application of control product B (10 times).
Interventions/Control_4	Application of control product C (10 times).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	22 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	[1]Males or females aged 22-59 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 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	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.jp

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	2019 Year 03 Month 13 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	2019 Year 03 Month 06 Day
Date of IRB	2019 Year 03 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 24 Day
Last follow-up date	2019 Year 03 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 06 Day
Last modified on	2019 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041111