UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056706 |
|---|---|
| Receipt number | R000064820 |
| Scientific Title | Skin Evaluation Test after 8 Weeks of Test Product Intake |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/14 10:06:33 |
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Basic information
Public title
Skin Evaluation Test after 8 Weeks of Test Product Intake
Acronym
Skin Evaluation Test after 8 Weeks of Test Product Intake
Scientific Title
Skin Evaluation Test after 8 Weeks of Test Product Intake
Scientific Title:Acronym
Skin Evaluation Test after 8 Weeks of Test Product Intake
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The test is conducted with the aim of verifying changes in skin condition when test food is consumed for 8 weeks among Japanese women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. stratum corneum water content
2. dermal water content
3. transepidermal water transpiration
4. skin viscoelasticity
5. VISIA image analysis
6. fine wrinkle image evaluation
7. VECTRA Evaluation
8. skin thickness evaluation
9. tape stripping
10. visual evaluation by a medical specialist
Key secondary outcomes
1. subjective questionnaire
2. logbook
--
Other safety evaluation items include
1. interview and visual evaluation by a physician
2. physical examination (height, weight, BMI) *Height and BMI are performed only during SCR
3.Adverse events
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
Test product (once a day, 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese women between the ages of 40 and 59
2. Subjects those with visual fine wrinkle grade1.00-3.00
3.Subjects non-users of anti-wrinkle cosmetics and quasi-drugs (e.g., containing retinol) in the last 3 months
4.Those who usually take care of their skin after washing their face with relatively simple care consisting of 1-3 products such as toner, milky lotion, essence, etc.
5. Subjects who can abstain from alcohol from the day before the measurement day until the end of the measurement
6. Subjects who are able to obtain written consent based on their own free will prior to the start of the study.
Key exclusion criteria
1. Subjects those with chronic skin conditions such as atopic dermatitis, contact dermatitis, skin hypersensitivity, etc.
2. Subjects those with skin conditions that may affect the evaluation of the face as the test site
3. Subjects who experience in cosmetic medicine that affects the subject area
4. Subjects who have not received special facial care (facial equipment, esthetics, peeling, laser, etc.) for more than one month as of the date of obtaining consent
5. Subjects who have hay fever and are taking medication
6. Subjects those with allergies (drugs, food)
7. Subjects who regularly use drugs, quasi-drugs, supplements, health foods, etc. that claim to have skin beautifying effects or that may affect this study
8. Subjects whose not undergoing hormone replacement therapy for menopausal symptoms as of the date of consent, or not older than 6 months after the therapy
9. Subjects who are on a daily diet or have extremely irregular eating habits
10. Subjects with extreme sunburn or who cannot avoid prolonged outdoor work or sports
11. Subjects who excessive smoking and drinking habits and extremely irregular eating habits
12. Subjects who plan to travel abroad or go swimming in the sea between the screening and the end of the examination
13. Subjects who are lactating or pregnant, or who wish to become pregnant during the study period
14. Subjects or Subject's family is in the following occupations [cosmetics, mass media, research, clinical trial organization]
15. Subjects who have participated in a clinical trial within 4 weeks of the date consent was obtained
16. Subjects who are currently participating or will participate in another clinical trial or clinical study during the study period
17. Subjects who are judged as ineligible to participate in the study by the principal investigator and the study investigator
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Tsukamoto |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsuminishi, Ikuno-ku, Osaka-shi, Osaka-fu, Japan
TEL
06-6758-9848
kouseit@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yukiyoshi |
| Middle name | |
| Last name | Katsumata |
Organization
Dermalabo Co., Ltd.
Division name
Clinical Research Group
Zip code
060-0001
Address
5F, Kogin building, 5-2 Kita1-jo nishi, Chuo-ku, Sapporo-shi, Hokkaido, Japan
TEL
011-205-0781
Homepage URL
y.katsumata@dermalabo.co.jp
Sponsor or person
Institute
Dermalabo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical 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
Ethics Committee of Sapporo Dermatology Clinic, kojinkai Medical Corporation
Address
6F, H&B Plaza Building, 1-1, Nishi 2-chome, Minami 3-jo, Chuo-ku, Sapporo-shi, Hokkaido, Japan
Tel
011-207-1066
tikenjimukyoku@kojinkai.org
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
デルマラボ株式会社
（Dermalabo Co., Ltd., 5F, Kogin building, 5-2 Kita1-jo nishi, Chuo-ku, Sapporo-shi, Hokkaido, Japan）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 14 | 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
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 16 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064820
