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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020393
Receipt No. R000023550
Scientific Title The commissioned test 1 of using body cleansing by medical staffs
Date of disclosure of the study information 2016/01/07
Last modified on 2018/01/23

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Basic information
Public title The commissioned test 1 of using body cleansing by medical staffs
Acronym The commissioned test of using body cleansing by medical staffs
Scientific Title The commissioned test 1 of using body cleansing by medical staffs
Scientific Title:Acronym The commissioned test of using body cleansing 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 the new body cleansing 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

Not applicable
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 40

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

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Asaoka
Organization Kao Corporation
Division name Household lab.
Zip code
Address 1334 Minato, Wakayama-city, Wakayama prefecture, Japan
TEL 073-426-7995
Homepage URL
Email asaoka.kentarou@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 Department of Infection Control and Laboratory Diagnostics, Internal Medicine, Tohoku University Graduate School of Medicine
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 泉整形外科病院(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 12 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
2015 Year 12 Month 29 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023550

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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