UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052967 |
|---|---|
| Receipt number | R000060434 |
| Scientific Title | Effects of cosmetic ingredients for skin microbiota and skin condition |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2024/04/30 09:13:38 |
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Basic information
Public title
Effects of cosmetic ingredients for skin microbiota and skin condition
Acronym
Effects of cosmetic ingredients for skin microbiota and skin condition
Scientific Title
Effects of cosmetic ingredients for skin microbiota and skin condition
Scientific Title:Acronym
Effects of cosmetic ingredients for 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 effects of test cosmetics for skin microbiota and skin condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin microbiota
Key secondary outcomes
Water content of stratum corneum
Transepidermal water loss
Sebum
pH
Image analysis of facial skin
Skin questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics (Essence) to the designated left or right half face during 4 weeks.
Interventions/Control_2
Apply placebo cosmetics (Essence) to the designated left or right half face during 4 weeks.
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) 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 contain the ingredient involved in this study or claim to have an effect on the skin microbiota.
2) Routinely do not use skin care cosmetics.
3) With a preexsiting or current condition of skin allergies.
4) 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.).
5) Will take antibiotics or steroids during the test period.
6) Wiith trauma or inflammation of the scalp or face.
7) Receiving hormone replacement therapy (estrogen, progesterone preparations (oral, paste, ointment, etc.)).
8) Have got cosmetic surgery which would affect the measuring area within 1 year.
9) Will get sunburned during the test period.
10) Will receive special treatment (epilation, facial esthetics, etc.) during the test period.
11) Can not maintain regular lifestyle.
12) Have an irregular habit because of working at night or working under work-shift form.
13) Drink more than 500 mL of beer equivalent daily.
14) Have been smoking (including electronic cigarettes) for 3 months prior to obtaining consent.
15) Participated in other clinical trial within 1 month.
16) Working at the health food, cosmetics or pharmaceutical company.
17) Deemed inappropriate to participate in this study by the principle investigator.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Okumura |
Organization
Yamada Bee Company, Inc.
Division name
YamadaBee 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
YamadaBee 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 | 12 | Month | 11 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060434
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| Research case data specifications | |
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| Registered date | File name |
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