UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020393
Receipt number 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 07:32:55

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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 or person

Institute

Kao Corporation, Household lab.

Institute

Department

Personal name



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

Value
https://center6.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