UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055873 |
|---|---|
| Receipt number | R000063855 |
| Scientific Title | Placebo-controlled, double-blind, randomized, parallel-group comparative study to investigate the effectiveness of ingesting test product (symbols: X and Y) on dermal moisture content. |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/09/29 18:15:00 |
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Basic information
Public title
Clinical trial to confirm the effect of test product intake on improving skin moisture
Acronym
Clinical trials on test product
Scientific Title
Placebo-controlled, double-blind, randomized, parallel-group comparative study to investigate the effectiveness of ingesting test product (symbols: X and Y) on dermal moisture content.
Scientific Title:Acronym
Test product intervention study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effectiveness of ingesting the test product for 12 weeks on the skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moisture content of the dermis
Key secondary outcomes
Skin viscoelasticity
Blood factors
Skin carotenoid levels
Full face photo
questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous consumption for 12 weeks of a beverage containing the test substance
Interventions/Control_2
Continuous consumption for 12 weeks of Placebo beverage
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Persons who meet all of the following conditions will be selected.
1.Individuals who have expressed a desire to participate in the study, understood the explanation, and can provide written consent to participate in the study
2. Healthy Japanese women aged 35-50
3. Individuals who are aware of a lack of vegetables
4. Individuals who are concerned about a decrease in skin elasticity
5. Individuals with a regular lifestyle (those who wake up in the morning and go to bed at night, with relatively regular wake-up and bedtimes)
6. Individuals who are able to fill out documents such as consent forms, questionnaires, and test product intake diaries
Key exclusion criteria
Those who meet even one of the following conditions will be excluded.
1. Taking medicines, foods for specified health uses, functional foods, health foods, or beauty supplements that claim to have moisturizing effects, skin elasticity maintenance effects, or estrogen-like effects (3 times or more per week)
2. Taking supplements containing carotenoids (3 times or more per week)
3. Taking concentrated mixed vegetable juice, mixed vegetable and fruit juice, tomato juice, carrot juice, orange juice, green juice, or mango juice (3 times or more per week)
4. Taking carrots, pumpkin, spinach, or chrysanthemums (3 times or more per week)
5. Having significant abnormalities in the skin condition of the test site
6. Having had cosmetic medical treatment that could affect the test site
7. Having not yet received facial or body beauty treatment for more than one month ago
8. Atopic dermatitis, etc. 9. Currently visiting a doctor and using medicines
10. BMI is less than 18.5 and more than 25
11. Smoker
12. Excessive alcohol intake
13. Asthma
14. Hay fever
15. Pregnant or planning to be pregnant, or breastfeeding
16. Currently participating in a study involving the ingestion of other beverages or medicines, or a study involving the application of cosmetics or medicines, or participating in a similar study and having completed the study more than 3 months ago
17. May develop allergic symptoms from ingesting the test product
18. Planning to travel overseas or take a long domestic trip during the study period
19. Night shift or two-shift work (different from the daily rhythm of waking up in the morning and going to bed at night)
20. Other subjects that the study director or study manager deems inappropriate (uncooperative subjects, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Toyoda |
Organization
SHISEIDO CO., LTD.
Division name
MIRAI Technology Institute
Zip code
220-0011
Address
1-2-11, Takashima, Nishi-ku, Yokohama-shi, Kanagawa-ken
TEL
045-222-1600
masahiko.toyoda@shiseido.com
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward, inc
Division name
Ebisu skin research center
Zip code
150-0013
Address
Sankei 51 Building 5F, 1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
Homepage URL
sakurai@inforward.co.jp
Sponsor or person
Institute
SHISEIDO CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAGOME CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Center
Address
2972-8-603, Ishikawamachi, Hachioji-chi, Tokyo, Japan
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
SD-2024-11-007
Org. issuing International ID_1
Inforward, inc
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 | 12 | Month | 31 | 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 | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063855
