UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061470 |
|---|---|
| Receipt number | R000070342 |
| Scientific Title | Research on the effects of black tea polyphenols on the skin |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 13:44:19 |
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Basic information
Public title
Research on the effects of black tea polyphenols on the skin
Acronym
Research on the effects of black tea polyphenols on the skin
Scientific Title
Research on the effects of black tea polyphenols on the skin
Scientific Title:Acronym
Research on the effects of black tea polyphenols on the skin
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on skin condition when black tea is ingested continuously for 8 weeks by adult women aged 30 to 49.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin examination (stratum corneum hydration, transepidermal water loss, skin viscoelasticity, and VISIA image analysis) at baseline, 4 weeks, and 8 weeks after the start of intake.
Key secondary outcomes
Urinary 8-OHdG, and VAS questionnaire (skin condition, physical condition, and bowel movements) at baseline, 4 weeks, and 8 weeks after the start of intake.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 1,050 mL of the test food (black tea) once a day, daily for 8 weeks.
Interventions/Control_2
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2) Japanese females who are 30 years old or more and under 50 years old at the time of informed consent.
3) Persons who have concerns about their skin.
Key exclusion criteria
1) Persons who have chronic illness, receiving medication, or have a serious disease history.
2) Persons who are allergic to the test food.
3) Persons who usually take a large amount of black tea (3 cups or more per day).
4) Persons who usually take medicine, health foods (specified health foods, functional foods, and functional nutrition foods), or other supplements expected to have cosmetic effects.
5) Persons who have experienced cosmetic medicine on the face.
6) Persons who have inflammation or skin disease on the face.
7) Persons receiving hormone replacement therapy.
8) Persons with eyelash extensions.
9) Persons with permanent makeup on the corners of the eyes.
10) Persons whose measurement date may overlap with their menstrual period.
11) Persons who may develop seasonal allergic symptoms such as hay fever and may use medications during the study period.
12) Persons who have participated in other studies within one month before the start of the study, or who plan to participate in another study after consenting to this study.
13) Persons who were judged as inappropriate for study participants by the principal investigator or the research director.
14) Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Integrate 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
0368092722
soumu@hc-sys.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
| 2026 | Year | 05 | Month | 07 | 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
| 2026 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070342
