UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057168 |
|---|---|
| Receipt number | R000064890 |
| Scientific Title | Effects of foods containing plant extracts on the skin in middle-aged and older adults _preliminary examination |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/28 13:46:49 |
* 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
Effects of foods containing plant extracts on the skin in middle-aged and older adults
Acronym
Effects of foods containing plant extracts on the skin in middle-aged and older adults
Scientific Title
Effects of foods containing plant extracts on the skin in middle-aged and older adults _preliminary examination
Scientific Title:Acronym
Effects of foods containing plant extracts on the skin in middle-aged and older adults_preliminary examination
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary data collection on the effects of these products on wrinkles in middle-aged and older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Collection of periorbital skin replicas:
using the optical 3D skin measurement device PRIMOS CR and the analysis application PRIMOS ver.5.8, periorbital skin replicas will be photographed. Wrinkle grade evaluation will be conducted through three-dimensional analysis using PRIMOS CR.
Key secondary outcomes
Facial skin image analysis
Skin photography
Skin color
Water Vapor Transpiration
Amount of moisture in the stratum corneum
Cutaneous viscoelasticity
Elastin measurement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week continuous consumption of the test food product
Interventions/Control_2
No consumption _control group
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy Japanese men aged 40 to 65 years
Key exclusion criteria
1) Individuals with a potential risk of allergic reactions to the plant extract used as the test material.
2) Individuals with severe atopic dermatitis.
3) Individuals with a history of allergies to cosmetics or drugs, or those with sensitive skin.
4) Individuals with severe cardiac, renal, hepatic disorders, or suspected/known cardiovascular diseases.
5) Individuals who have undergone treatments affecting facial skin function (e.g., chemical peels, laser treatments, or prescribed medications such as hydroquinone, high-dose vitamin C, or retinoic acid) within the past 3 months.
6) Individuals who regularly use medications or supplements aimed at improving wrinkles (e.g., retinol-based products, collagen-containing supplements, drinks) and cannot cease their use 1 month prior to the trial.
7) Individuals likely to use anti-allergy medications during the study period.
8) Individuals participating in other clinical trials.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Tamie |
| Middle name | |
| Last name | Suzuki |
Organization
FANCL Corporation
Division name
Fundamental Technology Research Center for Health and Beauty , FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
TEL
045-820-3857
tamisuzuki@fancl.co.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | watanabe |
Organization
FANCL Corporation
Division name
Fundamental Technology Research Center for Health and Beauty , FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
TEL
045-820-3699
Homepage URL
rie1506@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
FANCL Corporation Ethics Committee
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
Tel
045-820-3803
chshinde@fancl.co.jp
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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064890
