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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031520
Receipt No. 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

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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
Institute The department of Dermatology ,Toho University Omori Medical Center
Institute
Department

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
URL(English) https://upload.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


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