UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056805 |
|---|---|
| Receipt number | R000064894 |
| Scientific Title | Evaluation of the aging care effect of cosmetics containing royal jelly |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/08/19 11:40:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the aging care effect of cosmetics containing royal jelly
Acronym
Evaluation of the aging care effect of cosmetics containing royal jelly
Scientific Title
Evaluation of the aging care effect of cosmetics containing royal jelly
Scientific Title:Acronym
Evaluation of the aging care effect of cosmetics containing royal jelly
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
Water content of stratum corneum
Transepidermal water loss
Skin glossiness
Skin color
Skin thickness
VISIA image analysis
Pore structure
Smart Skin Care's score
Sagging skin
Skin questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Only one side of the face, apply test cosmetics for 12 weeks.
Interventions/Control_2
The other side of the face, do not apply test cosmetics for 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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Subjects who feel skin aging (wrinkle, elasticity, sagging).
2) A healthy Japanese females aged 50-80 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
1) Subjects using cosmetics that contain the ingredient involved in this study.
2) Subjects at risk for allergy to the test cosmetics.
3) Subjects with cosmetic allergies.
4) Subjects attending or planning to attend dermatology clinics (for treatment of atopic dermatitis, etc.).
5) Subjects with scraped or inflamed skin on the measuring area.
6) Subjects receiving hormone replacement therapy (estrogen, progesterone preparations (oral, paste, ointment, etc.)).
7) Subjects who have got cosmetic medical treatment (hyaluronic acid injections, etc.) which would affect the measuring area within 1 year.
8) Subjects who cannot avoid sunburn during the test period.
9) Subjects who cannot be prohibited from receiving beauty care (facial esthetics, epilation, etc.).
10) Subjects who cannot maintain regular lifestyle.
11) Subjects who have an irregular habit because of working at night or working under work-shift form.
12) Subjects who drink more than 500 mL beer daily.
13) Subjects who have been smoking (including electronic cigarettes) for 3 months prior to obtaining consent.
14) Subjects who participated in other clinical trial within last 1 month.
15) Subjects working at the health food, cosmetics or pharmaceutical company.
16) Subjects using cosmetic, quasi-drugs, healthy foods that may affect the test.
17) Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nikaido |
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
tn2381@yamada-bee.com
Public contact
Name of contact person
| 1st name | Chizuru |
| Middle name | |
| Last name | Fujikura |
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
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
irb@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
| 2025 | Year | 02 | 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
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
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064894
