UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058953 |
|---|---|
| Receipt number | R000067423 |
| Scientific Title | Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety of long-term intake |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/01 17:07:17 |
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Basic information
Public title
Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety
Acronym
Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety
Scientific Title
Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety of long-term intake
Scientific Title:Acronym
Evaluation of the effect of plant-derived ingredient on the skin moisturizing function and safety
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of a plant-derived ingredient on the skin moisturizing effects and long-term safety in healthy Japanese men and women aged 20 years or older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The value of transepidermal water loss at 12 weeks after the start of intake
Key secondary outcomes
a. Evaluation of efficacy
･The value of skin water content at 12 weeks after the start of intake
･The value of stratum corneum cell area and degree of multiple exfoliation at 12 weeks after the start of intake
b. Evaluation of safety
The value of following items measured after 6 weeks and 12 weeks after the start of intake
･Body weight, body fat percentage, and BMI
･Hematological tests
･Blood biochemical tests
･General urine tests
･Number of cases and incidence rate of adverse reactions
･Number of cases and incidence rate of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of plant-derived ingredient capsules for 12 weeks
Interventions/Control_2
Ingestion of placebo capsules 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy Japanese men and women aged 20 to 59 at the time of obtaining consent to participate in the study
2.Individuals who are concerned about dry or flaky skin
Key exclusion criteria
1.Individuals currently suffering from any chronic illness and receiving treatment or medication
2.Individuals undergoing hormone replacement therapy
3.Individuals with chronic skin conditions such as atopic dermatitis
4.Individuals who have a habit if ingesting or applying medications for disease treatment within the past month
5.Individuals with severe anemia
6.Individuals at risk of allergic reactions to food or medications
7.Individuals who currently have, or have had within the past three months, a habit of consuming medications, quasi-drugs, specific health foods, nutritional supplements, functional foods, or so-called health foods that claim to have skin moisturizing effects
8.Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day for men and 20 g/day for women
9.Individuals with a smoking habit
10.Individuals who work night shifts
11.Individuals whose lifestyle habits may change during the study period
12.Individuals who may experience itching or other symptoms at the evaluation areas due to seasonal allergic symptoms such as hay fever during the study period. Additionally, individuals who may take anti-allergic medications or use nasal sprays
13.Individuals who cannot avoid intentional exposure to direct sunlight, such as sunbathing, during the study period
14.Individuals who have undergone cosmetic procedures in the evaluation areas
15.Individuals using medications, quasi-drugs, or cosmetics with strong moisturizing effects or potential effects on wrinkles
16.Individuals with abnormalities such as wounds or inflammation in the evaluation areas
17.Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
18.Individuals currently participating in other clinical studies or those who have participated in other clinical studies within the past three months
19.Any other individuals deemed ineligible for this study by the principal investigator
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
G167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno, Taito-ku, Tokyo
TEL
03-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME 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
KAGOME CO.,LTD. Research Ethics Review Committee
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
IRB@kagome.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 | 09 | Month | 01 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 23 | 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 | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067423
