UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031520
Receipt number R000035990
Scientific Title Relationship study between skin resident bacteria and skin
Date of disclosure of the study information 2018/03/02
Last modified on 2018/02/28 20:20:58

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Basic information

Public title

Relationship study between skin resident bacteria and skin

Acronym

Relationship study between skin resident bacteria and skin

Scientific Title

Relationship study between skin resident bacteria and skin

Scientific Title:Acronym

Relationship study between skin resident bacteria and skin

Region

Japan


Condition

Condition

Healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the skin's effect of skin resident bacteria

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of skin condition and skin surface bacterial 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

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Skin resident bacteria is applied to the half face and placebo to the opposite side twice a week. Intervention is carried out for 4 weeks.

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

30 years-old <=

Age-upper limit

39 years-old >=

Gender

Female

Key inclusion criteria

1. 30's healthy Japanese woman who care about skin dryness, conspicuous pores and facial dullness.
2. 30's healthy Japanese women who don't live with infants and elderly people.

Key exclusion criteria

1. Person who has symptoms of atopic dermatitis, cosmetic dermatitis, milk allergy.
2. Person with acne / folliculitis / scar on the cheek, under dental treatment.
3. Person who daily takes internal medicines for external antibacterial, steroid, anti-allergic, immunosuppressants, antihistamines.
4. Person who has pollinosis allergy disease.
5. Person who visits and is treated
in the dermatology department.
6. Person who daily uses external agent for the treatment of skin.
7. Pregnant or lactating person.

Target sample size

13


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiromi Kanto

Organization

Toho University Omori Medical Center

Division name

The department of Dermatology

Zip code


Address

5-21-16,Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Email

hiromi@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromi Kanto

Organization

Toho University Omori Medical Center

Division name

The department of Dermatology

Zip code


Address

5-21-16,Omori-Nishi, Ota-ku, Tokyo, Japan

TEL

03-3762-4151

Homepage URL


Email

hiromi@med.toho-u.ac.jp


Sponsor or person

Institute

The department of Dermatology ,Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

POLA Chemical Industries

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

POLA Chemical Industries

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

東邦大学医療センター大森病院
Toho University Omori Medical Center


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 02 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 03 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 11 Day

Last follow-up date

2017 Year 10 Month 12 Day

Date of closure to data entry

2017 Year 11 Month 22 Day

Date trial data considered complete

2017 Year 11 Month 30 Day

Date analysis concluded

2017 Year 12 Month 22 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 28 Day

Last modified on

2018 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035990


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name