UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054124 |
|---|---|
| Receipt number | R000061799 |
| Scientific Title | Evaluation of the skin penetration of cosmetics containing honeybee products |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/08/07 16:23:08 |
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Basic information
Public title
Evaluation of the skin penetration of cosmetics containing honeybee products
Acronym
Evaluation of the skin penetration of cosmetics containing honeybee products
Scientific Title
Evaluation of the skin penetration of cosmetics containing honeybee products
Scientific Title:Acronym
Evaluation of the skin penetration of cosmetics containing honeybee products
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the influence of skin conditions on the skin penetration of RJ components using the tape stripping technique.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of skin penetration of the RJ components (Tape stripping)
Key secondary outcomes
Water content of stratum corneum
Transepidermal water loss
pH
Sebum
Skin texture
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 6 mg/cm2 (37.5 mg total) of royal jelly cream to the inner forearm 2.5 cm square for 2 hours.
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Japanese females aged 40-60 years.
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
1) Subjects using cosmetics containing royal jelly.
2) Subjects diagnosed with atopic dermatitis and skin hypersensitivity.
3) Subjects attending or planning to attend dermatology clinics (for treatment of atopic dermatitis, etc.).
4) Pregnant or lactating women.
5) Subjects undergoing hospitalization and medication for the treatment of disease.
6) Subjects who have factors or symptoms on the skin of the inner forearm which may affect the test results or who have received cosmetic medical treatment.
7) Subjects receiving hormone replacement therapy (estrogen, progesterone preparations (oral, paste, ointment, etc.)).
8) Subjects who cannot avoid sunburn during the test period.
9) Subjects who work or exercise outdoors for long time.
10) Subjects who cannot be prohibited from receiving beauty care (facial esthetics, epilation, etc.).
11) Subjects participating in another clinical trial.
12) Subjects who have seasonal allergic symptoms such as hay fever and are taking medication during the test period.
13) Subjects taking bee products such as royal jelly and propolis.
14) Subjects who are judged as unsuitable for this study by the investigator.
Target sample size
10
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 | Yuki |
| Middle name | |
| Last name | Haruna |
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
yh2064@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
| 2024 | Year | 04 | Month | 15 | 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
10
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
| 2024 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061799
