UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056860 |
|---|---|
| Receipt number | R000064964 |
| Scientific Title | Effect of maintaining and improving skin quality by cosmetics containing olive-derived ingredients |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/05/09 17:06:18 |
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Basic information
Public title
Effect of maintaining and improving skin quality by cosmetics containing olive-derived ingredients
Acronym
Effects of olive-containing cosmetics on skin quality
Scientific Title
Effect of maintaining and improving skin quality by cosmetics containing olive-derived ingredients
Scientific Title:Acronym
Effects of olive-containing cosmetics on skin quality
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the olive-derived ingredient, Nuezenide, is effective in maintaining and improving skin elasticity through clinical trials in healthy person.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elasticity of the skin of face
Key secondary outcomes
The skin of face and arms: the hydration level of the skin surface (stratum corneum), Transepidermal Waterloss (TEWL), melanin and erythema
The skin of arms: Elasticity of skin
Subjective evaluation of skin quality
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Cosmetics containing olive ingredients are applied daily to the inner side of the right forearm for eight 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy women between the ages of 35 and 60
2.Those who can stop using cosmetics that have a wrinkle-relieving effect during use for 1 week before the test
3.Those who can continue to use the cosmetics as instructed during the period
4.Those who can give written consent
Key exclusion criteria
1.Pregnant women or persons who may become pregnant
2.Those who has a disease that is being treated or who are continuously taking medication prescribed by a doctor
3.Those who has caused allergies (including rashes) due to cosmetics or ointments
4.Those who is judged by the examiner to be ineligible to participate in the study
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture,Graduate school of Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka, Nishiku-Fukuoka City
TEL
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Nagae |
Organization
Faculty of Agriculture Graduate school of Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
815-8540
Address
Room 403, Open Design Laboratory Building 2 4-9-1, Shiobaru, Minami-ku Fukuoka City
TEL
092-553-9458
Homepage URL
sffps.hitoshiken@agr.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Agriculture,Graduate school of Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Agrume Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
3G Science LLC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
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 | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 26 | 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 | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064964
