UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of human skin microbiota with pre-intervention for sampling
Acronym	Human skin microbiome study with pre-intervention
Scientific Title	Analysis of human skin microbiota with pre-intervention for sampling
Scientific Title:Acronym	Human skin microbiome study with pre-intervention
Region	Japan

Condition
Condition	Skin disorder and healthy controls
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to understand the relationship between skin microbiota and the pathogenesis of skin disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin microbiome diversity
Key secondary outcomes	Shift of skin microbiome profiles with the change of disease state, treatments and the environment

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	7 days before your visit Skin prep instructions:No topical ointments, creams, lotions, petroleum jelly, and topical medicines to areas we want to sample. No swimming in chlorinated pools No antidandruff shampoo for 7 days before your appt. Avoid antibacterial soaps/gels/hand washes No perfume or cologne No phlebotomy or blood draw 24 hours before Clinic sampling visit No makeup applied 24 hrs before visit. No bathing, washing, swimming or shampooing for 24 hours before your appt. Do not wash your face prior to your skin sampling
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	0 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who are visiting Keio university division of Dermatology and/or National Center for Child Health and Development division of Allergy with written informed consent signed and dated. (2) Healthy individuals with written consent for participation in this study at RIKEN, Keio university division of Dermatology and National Center for Child Health and Development division of Allergy
Key exclusion criteria	None
Target sample size	460

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tamotsu Ebihara
Organization	Keio university school of medicine
Division name	Department of Dermatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	ebitamo@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Tamotsu Ebihara
Organization	Keio university school of medicine
Division name	Department of Dermatology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	ebitamo@yahoo.co.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	RIKEN Center for Integrative Medical Sciences Hiroshima University Graduate School of Biomedical and Health Sciences National Research Institute for Child Health & Development
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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 01 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	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 17 Day
Date of IRB	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 29 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029199