UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046292 |
|---|---|
| Receipt number | R000052125 |
| Scientific Title | Clinical trial for confirming the effects of improving skin transparency by ingesting the test product for 12 weeks |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/01/08 11:41:18 |
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Basic information
Public title
Test for confirming the effects of improving skin transparency by ingesting the test product for 3 months
Acronym
Test for confirming the effects of improving skin transparency by ingesting the test product for 3 months
Scientific Title
Clinical trial for confirming the effects of improving skin transparency by ingesting the test product for 12 weeks
Scientific Title:Acronym
Clinical trial for confirming the effects of improving skin transparency by ingesting the test product for 12 weeks
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify ingestion of test food for 12 weeks on skin transparency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin transparency
Key secondary outcomes
*Secondary index
[1]Observation for skin condition by dermatologists
[2]Cortisol
[3]Questionnaire of physical feeling
*Safety
[1]Doctor's questions
*Other index
[2]Subject's diary
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food containing plant mixed extract A (Tablets) for 12 weeks
Interventions/Control_2
Ingestion of test food containing plant mixed extract A and plant mixed extract B (Tablets) for 12 weeks
Interventions/Control_3
Ingestion of placebo food (tablets) for 12 weeks
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
1. Those who show their intention to participate in the exam, understand the explanation, and obtain written consent to participate in the exam.
2. Healthy Japanese women aged 35 to 50 wh
o do not violate the exclusion criteria
3. Those who can fill out documents such as consent forms, questionnaires, usage diaries, etc.
4. Those who have felt the effect on the skin with supplements etc.
5. Those who feel a decrease in skin transparency
6. Those who are concerned about skin color
7. People who tend to get frustrated
8. Those who are dissatisfied with sleep
Key exclusion criteria
1. At the time of obtaining consent, those who regularly use supplements that claim to beautify the skin, diet supplements, collagen supplements, and medicines that may be involved in skin quality (for example, Hythiol C)
2. Those who have significant abnormalities in the skin condition of the test site (face / inside the upper arm)
3. Those with food / drug allergies
4. Those who cannot stop drinking from the day before the measurement date to the end of the measurement
5. Those who smoke on a daily basis
6. Asthma
7. Those who have experience in aesthetic medicine that affects the test site
8. Those who have received a facial treatment and have not passed more than a month
9. Those with chronic skin symptoms such as atopic dermatitis, contact dermatitis, and skin hypersensitivity
10. Those who are currently going to the hospital and using medicines
11. Those who have developed hay fever and are taking medication
12. Those who have a major surgical history in the digestive system, those who have respiratory and heart problems
13. Those who are undergoing hormone replacement therapy for menopause or who have not passed more than 6 months after treatment
14. Those who are participating in a test of ingesting other foods or drugs, or applying cosmetics or drugs, or who have participated in a similar test and have not passed more than 3 months since participating
15. Those who are extremely sunburned or who cannot avoid long hours of outdoor work or sports
16. During lactation or pregnancy,or those who wish to become pregnant during the test period
17. In addition, those who are judged to be ineligible by the investigator and the person responsible for conducting the study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ueda |
Organization
Shiseido Co., Ltd.
Division name
Frontier Business R&D Center, MIRAI Technology Institute
Zip code
220-0011
Address
1-2-11, Takashima, Nishi-ku, Yokohama-shi, Kanagawa 220-0011, Japan
TEL
045-222-1600
osamu.ueda@shiseido.com
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Matsuzaka |
Organization
Dermalabo Co., Ltd.
Division name
Study Support group
Zip code
060-0001
Address
1-5-2, Chuou-ku, Sapporo-shi, Hokkaido 060-0001, Hokkaido
TEL
011-205-0781
Homepage URL
m.matsuzaka@dermalabo.co.jp
Sponsor or person
Institute
Shiseido Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shiseido Co., Ltd., TSUMURA & CO.
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
Tactics, Hokkaido Revitalization Center, Specified Nonprofit Corporation
Address
2-9 Chuou-ku, Sapporo-shi, Hokkaido, 060-0000, Japan
Tel
011-281-6783
yukiko.iw@gmail.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 | 01 | 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
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052125
