UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052636 |
|---|---|
| Receipt number | R000060058 |
| Scientific Title | Effects of medicated cosmetics containing royal jelly for skin conditions |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/07/08 17:53:06 |
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Basic information
Public title
Effects of medicated cosmetics containing royal jelly for skin conditions
Acronym
Effects of medicated cosmetics containing royal jelly for skin conditions
Scientific Title
Effects of medicated cosmetics containing royal jelly for skin conditions
Scientific Title:Acronym
Effects of medicated cosmetics containing royal jelly 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 test cosmetics for skin conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin elasticity
Key secondary outcomes
Sagging skin
Water content of stratum corneum
Transepidermal water loss
Image analysis of facial skin
Skin microbiota
Skin questionnaire
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply test cosmetics (combined use of lotion, essence, and cream) to whole face during 12 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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Subjects who feel skin aging (wrinkle, elasticity, pores, dryness).
2) A healthy Japanese females aged 40-70 at the time of consent.
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) Drink more than 500 mL of beer equivalent daily.
12) Have been smoking (including electronic cigarettes) for 3 months prior to obtaining consent
13) Participated in other clinical trial within 1 month.
14) Working at the health food, cosmetics or pharmaceutical company.
15) Constantly use cosmetic, quasi-drugs, healthy foods that may affect the test.
16) Deemed inappropriate to participate in this study by the principle investigator.
Target sample size
32
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 | Chizuru |
| Middle name | |
| Last name | Fujikura |
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
Homepage URL
ch1644@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 | 11 | 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
35
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 | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060058
