UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056326 |
|---|---|
| Receipt number | R000063892 |
| Scientific Title | Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2025/07/22 11:12:49 |
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Basic information
Public title
Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement
Acronym
Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement
Scientific Title
Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement
Scientific Title:Acronym
Preliminary study of the Effects of Test Food Intake on Skin Quality Improvement
Region
| Japan |
Condition
Condition
Female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This preliminary study is conducted to verify the skin quality improvement effects of the test food, in preparation for future planned trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum hydration
Skin viscoelasticity
Transepidermal water loss (TEWL)
Key secondary outcomes
Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral consumption of one sachet of the test food dissolved in hot water once 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
| 35 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female aged 35 to below 65 years at the time of consent acquisition.
2. Individuals who are aware of having dry skin.
3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria
1. Individuals who regularly consume Food for Specified Health Uses (FOSHU), functional foods, or health supplements (including those containing collagen, sodium hyaluronate, glucosyl ceramide, etc.) more than three times a week.
2. Individuals who cannot discontinue the intake of Food for Specified Health Uses (FOSHU), functional foods, or health supplements (including those containing collagen, sodium hyaluronate, glucosyl ceramide, etc.) from the time of consent.
3. Individuals using medications that could affect the trial outcomes, such as heparin analogs, urea, vaseline, or topical steroids.
4. Individuals with scars, bruises on measurement sites (left cheek, inner left forearm).
5. Individuals with skin irritation due to hay fever.
6. Individuals with extreme sunburn or those who engage in outdoor labor, work, or sports for extended periods.
7. Individuals planning a long-term overseas trip from the pre-test period through the end of the study.
8. Individuals receiving special care at external facilities for skin measurement areas (facial or body aesthetics, beauty devices, peeling, laser treatments, hair removal, etc.).
9. Individuals with excessive alcohol intake.
10. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs.
11. Females who are pregnant or lactating, and those who intend to become pregnant during the trial period.
12. Individuals with allergies to medications and/or food.
13. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
14. Individuals who donated 200 mL of their blood or blood components within the last month.
15. Individuals who donated 400 mL of their blood within the last 4 months.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Kunitaro 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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 | 11 | Month | 30 | 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
20
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
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
16. Individuals who have had a total of 800 mL of their blood collected within the last 12 months, including in this study.
17. Individuals deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063892
