UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship study between skin resident bacteria and skin
Title of the study (Brief title)	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	Hiromi Kanto
Organization	Toho University Omori Medical Center
Division name	The department of Dermatology
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	Hiromi Kanto
Organization	Toho University Omori Medical Center
Division name	The department of Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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