UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025471 |
|---|---|
| Receipt number | R000029199 |
| Scientific Title | Analysis of human skin microbiota with pre-intervention for sampling |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/01/28 12:22:09 |
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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
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
ebitamo@yahoo.co.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029199
