UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050147 |
|---|---|
| Receipt number | R000056950 |
| Scientific Title | Confirmation study on skin-improving effects by test-food intakes |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/06/24 14:48:13 |
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Basic information
Public title
Confirmation study on skin-improving effects by test-food intakes
Acronym
Confirmation study on skin-improving effects by test-food intakes
Scientific Title
Confirmation study on skin-improving effects by test-food intakes
Scientific Title:Acronym
Confirmation study on skin-improving effects by test-food intakes
Region
| Japan |
Condition
Condition
Healthy female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate whether test-food intakes for six weeks can reveal some kind of improvement effect on skin function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin function
(stratum corneum moisture-binding capacity, skin viscoelasticity and moisture-evaporating capacity)
Key secondary outcomes
1. Stress Check List 30
2. Visual Analog Scale questionnaire for a mood.
3. State-Trait Anxiety Inventory
4. Questionnaires about skin condition and sleep awareness
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
Consumption of the test food (four times a day, one drop each) without chewing for six weeks.
Interventions/Control_2
Consumption of the placebo food (four times a day, one drop each) without chewing for six 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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy female subjects ranging in age from 35 to 49, at informed consent.
(2) Subjects who feel their skin dryness, and the failure of skin elasticity.
(3) Subjects who can give informed consent to partake in this study after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who take steadily (not less than three times a week) in affecting health-specific/functional (e.g., sodium hyaluronate, glucosylceramide, astaxanthin)/supplementary/health foods.
(2) Subjects who have taken affecting medicines (e.g., moisturizer), and have any difficulty in refraining from taking them, during this study.
(3) Subjects having a bruise and/or a hurt near the skin-measuring position (buccal region).
(4) Subjects having their skin roughness due to pollinosis.
(5) Subjects with excessive suntan, or working and playing sports outside for long hours.
(6) Subjects planning to travel abroad during this study.
(7) Subjects being under a specific care on their face (e.g., facial treatment, body care, electric facial, peeling, laser therapy, and hair removal) at an outside agency.
(8) Subjects with excessive alcohol intake.
(9) Subjects having a habit of smoking.
(10) Subjects having previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11) Subjects with pregnancy, possibly one, or lactating.
(12) Subjects with drug and food allergy.
(13) Subjects suffering from atopic dermatitis, contact one, and cutaneous sensitivity.
(14) Subjects being under other clinical tests with medicine or health food, or partook in those within four weeks to this study, or planning to join those after giving informed consent.
(15) Subjects who donated over 200 mL of their blood and/or blood components within a month to this study.
(16) Subjects who donated their whole blood (400 mL) within the last four months to this study.
(17) Subjects who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(18) Subjects being determined as ineligible for participation, judging from the principal/sub investigator.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Ono |
Organization
Mitsui Norin Co.,LTD.
Division name
R & D
Zip code
426-0133
Address
223-1 Miyahara, Fujieda-shi, Shizuoka 426-0133, Japan
TEL
054-648-2600
a.ohno@mitsui-norin.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 103-0021, 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
Mitsui Norin 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
| 2024 | Year | 02 | 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
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056950
