UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049424 |
|---|---|
| Receipt number | R000056274 |
| Scientific Title | Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-1 |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2026/01/08 10:29:33 |
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Basic information
Public title
Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-1
Acronym
Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-1
Scientific Title
Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-1
Scientific Title:Acronym
Confirmation test of skin improvement effect by 3-month ingestion of beauty supplements containing herbal medicines-1
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the effect of improving the skin condition, mainly the barrier function, when the test product is ingested for 3 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TEWL
Key secondary outcomes
*Secondary index
[1]stratum corneum water content
[2]stratum corneum condition
[3]Questionnaire of physical feeling
*Safety
[1]Doctor's questions
*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
2
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 group:Test food containing mixed plant extract A and mixed plant extract B
Take tablets for 12 weeks
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
1. Those who indicate their intention to participate in the test, understand the explanation, and obtain written consent to participate in the test
2. Healthy Japanese women between the ages of 35 and 50 who do not meet the exclusion criteria
3. Those who can fill in documents such as consent forms, questionnaires, test product intake diaries, etc.
4. Subjects who have felt effects on the skin with supplements, etc.
5. Those who feel rough skin
6. Those who feel a decrease in skin moisture
7. People with dry skin
8. Individuals who feel that their stomach is weak on a daily basis
9. Persons who feel that bowel movements (constipation, loose stools) are not good
Key exclusion criteria
Those who meet even one of the following conditions will be excluded.
1. Those who currently use skin care and diet supplements, collagen supplements, and pharmaceuticals on a regular basis
2. Persons who cannot abstain from drinking from the day before the measurement to the end of the measurement
3. Those who smoke on a daily basis
4. Person with asthma
5. Those who are pregnant or planning to become pregnant, those who are breastfeeding
6. Those who have hay fever (those who do not take hay fever medicine are allowed)
7. Persons with food allergies
8. Tests of ingesting other foods and drugs, and applying cosmetics and drugs
who are currently participating in a similar study or who have been participating in a similar study for at least 3 months
who have not passed
9. In addition, those who are judged to be unsuitable by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ueda |
Organization
Shiseido Co., Ltd.
Division name
MIRAI Technology Institute
Zip code
220-0011
Address
1-2-11, Takashima, Nishi-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-222-1600
osamu.ueda@shiseido.com
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Sakurai |
Organization
Inforward Co., Ltd.
Division name
Ebisu Skin Research Center
Zip code
150-0013
Address
5th floor, 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
Shiseido Co., Ltd.
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 Rese arch Review Center
Address
2972-8-603 Ishikawamachi Hachioji-shi,Toky o,192-0032,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
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
63
Results
Improvements in TEWL were observed on the cheeks at 8 and 12 weeks.
Improvements in stratum corneum moisture content were observed on both the cheeks and arms from 4 weeks onwards.
Results date posted
| 2026 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Those who indicate their intention to participate in the test, understand the explanation, and obtain written consent to participate in the test
2. Healthy Japanese women between the ages of 35 and 50 who do not meet the exclusion criteria
3. Those who can fill in documents such as consent forms, questionnaires, test product intake diaries, etc.
4. Subjects who have felt effects on the skin with supplements, etc.
5. Those who feel rough skin
6. Those who feel a decrease in skin moisture
7. People with dry skin
8. Individuals who feel that their stomach is weak on a daily basis
9. Persons who feel that bowel movements (constipation, loose stools) are not good
Participant flow
Subjects selected based on the inclusion and exclusion criteria were screened to select 66 subjects with high TEWL.
The 66 subjects were randomly divided into two groups, with 33 receiving the placebo and 33 receiving the test product, and the study began.
Subjects took the product once daily for 12 weeks, with skin measurements taken on the start of the study and every four weeks up to week 12.
Adverse events
Nothing in particular
Outcome measures
Transepidermal water loss
Stratum corneum water content
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 04 | 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=R000056274
