UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059890 |
|---|---|
| Receipt number | R000068486 |
| Scientific Title | Effects of consumption of the test food on the skin of healthy Japanese: an open-label study |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 10:30:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of consumption of the test food on the skin of healthy Japanese
Acronym
Effects of consumption of the test food on the skin of healthy Japanese
Scientific Title
Effects of consumption of the test food on the skin of healthy Japanese: an open-label study
Scientific Title:Acronym
Effects of consumption of the test food on the skin of healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Measured value of transepidermal water loss (TEWL) at 8 weeks after the intervention (8w)
Key secondary outcomes
1. Measured value of TEWL at 4 weeks after the intervention (4w)
2. Measured values of skin surface moisture at 4w and 8w
3. Measured values of skin viscoelasticity (R0-R9) at 4w and 8w
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
Duration: Eight weeks
Test product: Test food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who have recently experienced skin problems
Key exclusion criteria
1. Individuals currently undergoing treatment or with a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals with a pacemaker or implantable cardioverter defibrillator
3. Individuals currently undergoing treatment for chronic diseases such as cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
4. Individuals taking Foods for Specified Health Uses or Foods with Functional Claims
5. Individuals taking medicines (including herbal medicines) or supplements
6. Individuals with a history of atopic dermatitis
7. Individuals using daily skincare products other than toners, lotions, or sunscreen, such as creams, serums, all-in-one products, and masks
8. Individuals regularly receiving skincare treatments (e.g., aesthetic procedures) or using beauty devices (e.g., facial devices)
9. Individuals with a history of cosmetic surgery
10. Individuals who have undergone any procedures in the past 3 months that may affect the evaluation site, such as hormone replacement therapy, cosmetic procedures, or treatments for diseases requiring hospitalization
11. Individuals at risk of seasonal allergy symptoms, such as hay fever, during the study
12. Individuals whose lifestyle patterns may vary during the study (e.g., night shifts, business trips, or travel)
13. Individuals unable to refrain from deliberate exposure to sunlight, such as sunbathing, during the study
14. Individuals with allergies to medicines or foods related to the test product, particularly cacao allergy
15. Individuals who are pregnant, lactating, or planning to become pregnant during the study period
16. Individuals who participated in another clinical study within 28 days before consent or plan to participate in another study during the study
17. Individuals considered ineligible for the study by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Izumi |
Organization
Hiroo Dermatology Clinic & Mentors inc.
Division name
Director
Zip code
150-0012
Address
1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-5795-1112
dr_izumi@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
TOKIWA PHYTOCHEMICAL 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 ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068486
