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
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
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
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
