UMIN-CTR Clinical Trial

Basic information
Public title	The commissioned test of using Softy Ex-care form hand wash by medical staffs
Acronym	The commissioned test of using Softy Ex-care form hand wash by medical staffs
Scientific Title	The commissioned test of using Softy Ex-care form hand wash by medical staffs
Scientific Title:Acronym	The commissioned test of using Softy Ex-care form hand wash by medical staffs
Region	Japan

Condition
Condition	healthy subject
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation to the effect of skin by using body cleansing
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of living bacteria on the skin and skin condition after 1 month intervention
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	Treatment
Type of intervention	Other
Interventions/Control_1	To change Softy Ex-care form hand wash instead of habitually using in hospital, and subjects will use the new body cleansing for 4 weeks. The using times of body cleansing conform to CDC Guideline.
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	18 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Medical Staffs
Key exclusion criteria	1. Person who has a serious sickness at heart, lung, kidney, liver, blood, internal secretion, skin, etc. 2. Atopic dermatitis, contact dermatitis patient 3. Person of using steroid 4. Person who goes to hospital of department of dermatology. 5. Pregnant or nursing in a year.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaya Nishio
Organization	Kao Corporation
Division name	Household lab.
Zip code
Address	1334 Minato, Wakayama-city, Wakayama prefecture, Japan
TEL	073-426-7995
Email	nishio.masaya@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Noboru Matsuo
Organization	Kao Corporation
Division name	Household lab.
Zip code
Address	1334 Minato, Wakayama-city, Wakayama prefecture, Japan
TEL	073-426-7995
Homepage URL
Email	matsuo.noboru1@kao.co.jp

Sponsor
Institute	Kao Corporation Household lab.
Institute
Department

Funding Source
Organization	Kao Corporation Household lab.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tachikawa Chuo Hospital
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	立川中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 23 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	2017 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035273

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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