UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051436 |
|---|---|
| Receipt number | R000058631 |
| Scientific Title | Study of the relationship between skin microbiota and skin condition |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/02/01 18:14:20 |
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Basic information
Public title
Study of the relationship between skin microbiota and skin condition
Acronym
Study of the relationship between skin microbiota and skin condition
Scientific Title
Study of the relationship between skin microbiota and skin condition
Scientific Title:Acronym
Study of the relationship between skin microbiota and skin condition
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between skin microbiota and skin (cheek) condition of in 60's female.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin microbiota
Water content of stratum corneum
Transepidermal water loss
Sebum
pH
Image analysis of facial skin
Skin questionnaire
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) A healthy Japanese females aged 60-69 at the time of consent.
2) Subjects can understand and comply with the rules written in protocol during clinical study period.
3) Subjects whose written informed consent has been obtained.
Key exclusion criteria
The following exclusion criteria apply to subjects.
1) Routinely use cosmetics that claim to have an effect on the skin microbiota.
2) With a preexsiting or current condition of skin allergies.
3) Attend a dermatologist or cosmetic dermatologist for skin diseases on the scalp or face. (including those being treated for atopic dermatitis, seborrheic dermatitis, contact dermatitis, psoriasis, athlete's foot on the scalp, etc.)
4) With trauma or inflammation of the scalp or face.
5) Receiving hormone replacement therapy. (estrogen, progesterone preparations (oral, paste, ointment, etc.))
6) Have got cosmetic surgery which would affect the measuring area within 1 year.
7) Have got special treatment within 1 month. (facial esthetics, epilation etc.)
8) Have an irregular habit because of working at night or working under work-shift form.
9) Drink more than 500 mL of beer equivalent daily.
10) Have been smoking (including electronic cigarettes) for 3 months prior to obtaining consent.
11) Participated in other clinical trial within 1 month.
12) Working at the health food, cosmetics or pharmaceutical company.
13) Deemed inappropriate to participate in this study by the principle investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Okumura |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company group Institute for Beauty Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
no1780@yamada-bee.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabe |
Organization
Yamada Bee Company, Inc.
Division name
Yamada Bee Company group Institute for Beauty Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
03-6433-2248
Homepage URL
hk1926@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama
Tel
0868-54-1199
rt2067@yamada-bee.com
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
| 2023 | Year | 07 | 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
250
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
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study, Random sampling
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058631
