UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046343 |
|---|---|
| Receipt number | R000052080 |
| Scientific Title | Clinical trial for confirming skin improvement effect by ingesting test product for 12 weeks-2 |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/01/09 08:59:06 |
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Basic information
Public title
Test for confirming skin improvement effect by ingesting test product for 3 months-2
Acronym
Test for confirming skin improvement effect by ingesting test product for 3 months-2
Scientific Title
Clinical trial for confirming skin improvement effect by ingesting test product for 12 weeks-2
Scientific Title:Acronym
Clinical trial for confirming skin improvement effect by ingesting test product for 12 weeks-2
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the usefulness for the skin elasticity and skin moisture content is confirmed by taking a beauty supplement for 12 consecutive weeks for women aged 35 to 50 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin elasticity, skin moisture content
Key secondary outcomes
*Secondary index
[1]Component analysis in the stratum corneum
[2]Questionnaire of physical feeling
*Other index
[1]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
Placebo group : Placebo tablets
Take tablets for 12 weeks
Interventions/Control_2
Test product 1 group: Tablets containing plant mixed extract A
Take tablets for 12 weeks
Interventions/Control_3
Test product 2 group: Tablets containing plant mixed extract A and plant mixed extract B
Take 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 who 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 firmness
6. People with dry skin
7. Those who feel cold (limbs, etc.)
8. Those who feel stress and anxiety every day
Key exclusion criteria
1. Those who regularly use skin-beautifying and diet supplements, collagen supplements, and medicines
2. Those who cannot stop drinking from the day before the measurement date to the end of the measurement
3. Those who smoke on a daily basis
4. Person with asthma
5. Those who are pregnant or plan to do so, those who are breastfeeding
6. People with hay fever (People who do not take hay fever medicine are allowed)
7. People with food allergies
8. Those who are participating in the test of ingesting other foods and drugs, the test of applying cosmetics and drugs, or those who have participated in the same test and have not passed more than 3 months since the end.
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
MIRAI Technology InstituteFrontier Business R&D
Zip code
220-0011
Address
SHISEIDO CO., LTD.
TEL
045-222-1600
taro.uchiyama@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
1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL
03-5447-6411
Homepage URL
taro.uchiyama@shiseido.com
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
General Incorporated Association Crinical Research Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi,Toky o,192-0032,JAPAN
Tel
81-426-48-4368
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://smartconf.jp/content/jsp69/timetable
Number of participants that the trial has enrolled
93
Results
Improvements in elasticity and stratum corneum moisture content were observed in both cheeks and arms after 8 weeks in both test groups.
Results date posted
| 2026 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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 who 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 firmness
6. People with dry skin
7. Those who feel cold (limbs, etc.)
8. Those who feel stress and anxiety every day
Participant flow
Of the 180 subjects selected based on the inclusion and exclusion criteria, 99 subjects with low stratum corneum moisture content were selected through screening.
Subjects took the supplement once daily for 12 weeks, and skin measurements were taken on the start of the study and every four weeks.
Excluding dropouts, 93 subjects across the three groups were analyzed.
Adverse events
Nothing in particular
Outcome measures
Elasticity (main item), moisture content, TEWL, wrinkles, skin texture
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052080
