UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055126 |
|---|---|
| Receipt number | R000062759 |
| Scientific Title | Skin tone improvement effect test with food ingredients |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2024/07/31 15:41:23 |
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Basic information
Public title
Skin tone improvement effect test with food ingredients
Acronym
Skin tone improvement effect test with food ingredients
Scientific Title
Skin tone improvement effect test with food ingredients
Scientific Title:Acronym
Skin tone improvement effect test with food ingredients
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we will confirm the efficacy of beauty food ingredients on the skin of women who consume them for 12 consecutive weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin tone and transparency are measured every 4 weeks up to 12 weeks after the start of treatment
Key secondary outcomes
VISIA-Evolution imaging and analysis
Blood index
Urinary index
Blemish evaluation by a physician or skin tone evaluation
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 beauty supplement containing the test substance
Interventions/Control_2
Continuous consumption for 12 weeks of Placebo supplement
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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Persons who meet all of the following conditions will be selected. 1.
1. Persons who have indicated their willingness to participate in the study and who have given written consent to participate in the study based on their understanding of the explanations provided.
2. Healthy women residing in Japan (whose nationality is within the Asian region)
3. Women between the ages of 30 and 49 years old.
4. women with skin concerns such as skin lightness, dullness, blotches, etc.
5. Women who are aware that they fall under skin phototypes II or III.
6. who can agree to apply the specified sunscreen
7. Those who are able to fill out the consent form, questionnaire, daily logbook, etc.
Photoskin Type
Cited from the website of the Japanese Dermatological Association
Key exclusion criteria
Persons who meet at least one of the following conditions are excluded.
1. Persons with freckles, etc. that make measurement of the test site difficult.
2. Smokers
3. Persons with a history of hypersensitivity to food or food allergy.
4. Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
5. who have a history of co-morbidities or serious illnesses in the digestive organs
6. who are currently visiting the hospital and using or planning to use medicines or supplements.
7. who take or plan to take health foods, functional foods, or foods for specified health uses on a daily basis.
8. Persons who take or plan to take supplements or medicines containing ingredients such as vitamin C and L-cysteine (e.g., Chocola BB, Haitior C, Transino, Chimie White, and other "medicines effective against freckles and spots," and products with the trade names Mastigen BB Jelly, Chocola BB Plus, VitaSuppli B26L, Yokuinogen BC Tablets Pair Kampo Extract Tablets Pair A Tablets Haitior B Clear and other "drugs for acne") on a daily basis. 9.
9. who is currently participating in a medical, pharmaceutical, cosmetic, or food study, or who has participated in a similar study and has not completed it for at least 6 months, or who is scheduled to participate in it within this year.
10. a family member, including the participant, who is employed by a cosmetics, pharmaceutical, or food company.
11. who is pregnant or planning to become pregnant, or who is breast-feeding
12. Drinks alcohol every day (occasional moderate drinking is acceptable).
13. Those who consume excessive amounts of spicy food.
14. Persons who are likely to change their lifestyle during the study period.
15. who are using a skin whitening serum (quasi-drug)
etc.
Target sample size
44
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
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社インフォワード 恵比寿スキンリサーチセンター
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | 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 | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062759
