UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049871 |
|---|---|
| Receipt number | R000056760 |
| Scientific Title | Effects of honeybee products for Skin Conditions |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2023/09/04 15:45:20 |
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Basic information
Public title
Effects of honeybee products for Skin Conditions
Acronym
Effects of honeybee products for Skin Conditions
Scientific Title
Effects of honeybee products for Skin Conditions
Scientific Title:Acronym
Effects of honeybee products for Skin Conditions
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of honeybee products for skin conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wrinkle evaluation using the replica of eye corner[Max. depth biggest wrinkle]
Key secondary outcomes
Wrinkle grade evaluated using a picture of eye corner
Wrinkle evaluation using the replica of eye corner
Skin questionnaire
VISIA's indicators
Skin replica analysis (texture)
Skin thickness
Moisture and NMF in skin
Water content of stratum corneum
Stratum corneum tape stripping
Skin elasticity
Transepidermal water loss
Skin microbiota
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 (cream) to the designated left or right half face during 12 weeks.
Interventions/Control_2
Apply placebo cosmetics (cream) to the designated left or right half face during 12 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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Subjects who feel skin aging(wrinkle, elasticity, sagging).
2) Japanese females aged 40-60 years.
3) Subjects can understand and comply with the rules written in protocol during clinical study period.
4) Subjects whose written informed consent has been obtained.
Key exclusion criteria
The following exclusion criteria apply to subjects.
1) Constantly use cosmetic that contain the ingredient involved in this study.
2) With cosmetic allergies.
3) Visit dermatology department(for the purpose of treating atopic dermatitis etc.).
4) With inflamed or scraped skin on the measuring area.
5) Conducting hormone replacement therapy.
6) Have got cosmetic surgery which would affect the measuring area.
7) Will get sunburned during the test period.
8) Will receive special treatment (facial esthetics, epilation etc.) during the test period.
9) Can not maintain regular lifestyle.
10) Have an irregular habit because of working at night or working under work-shift form.
11) Drinks more than 500 mL beer daily.
12) A smoker.
13) Participated in other clinical trial within last 3 months.
14) Working at the health food, cosmetics or pharmaceutical company.
15) Constantly use cosmetic, quasi-drugs, healthy foods that may affect the test.
16) Judged not appropriate by principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Ikegami |
Organization
Yamada Bee Company, Inc.
Division name
Functional Ingredient research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
si1935@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
| 2022 | Year | 12 | Month | 23 | 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
70
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
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056760
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| Registered date | File name |
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