UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051832 |
|---|---|
| Receipt number | R000059152 |
| Scientific Title | Effect of the test food on skin viscoelasticity |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2024/02/05 08:45:28 |
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Basic information
Public title
Effect of the test food on skin viscoelasticity
Acronym
Effect of the test food on skin viscoelasticity
Scientific Title
Effect of the test food on skin viscoelasticity
Scientific Title:Acronym
Effect of the test food on skin viscoelasticity
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of test food intake on skin viscoelasticity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin viscoelasticity by Cutometer
Key secondary outcomes
(1) Stratum corneum water content by Corneometer
(2) Dermal thickness by DermaLab
(3) Wrinkle grade on the outer corner of the eyes by visual and photographic evaluation
(4) Wrinkle area percentage, total average depth of wrinkles, average depth of maximum wrinkles, and maximum depth of maximum wrinkles on the corner of the eyes using replica
(5) Blemishes, wrinkles, pores, color irregularities, porphyrins, hidden spots, melanin index, hemoglobin index by VISIA imaging
(6) TEWL by VAPOSCAN
(7) IL-1RA/IL-1 alpha, cell area, degree of multiple exfoliation, carbonylated proteins, and Involucrin/Nile red stain using tape-stripped stratum corneum
(8) Questionnaire
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
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Nucleotide containing capsule
Administration: Take two capsules per day at breakfast.
* If you forget to take a dose, take it within the same day and do not carry over to the next day.
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo capsule
Administration: Take two capsules per day at breakfast.
* If you forget to take a dose, take it within the same day and do not carry over to the next day.
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) Age between 20 and 60
(2) Male and female
(3) Subjects who are aware of dry skin
(4) Subjects who only use 1-2 items of lotion or milky lotion after washing their face (after bathing)
(5) Subjects who have received a sufficient explanation of the purpose and content of this study, have the ability to consent, and who voluntarily apply for participation after having a good understanding of the study, and who are able to give written consent to participate in this study.
Key exclusion criteria
1. Subjects who have urticaria, inflammation, eczema, trauma, acne, pimples, warts, blemishes, etc. or their traces on the evaluation site
2. Subjects with a history or current history of atopic dermatitis, or with atopic predisposition
3. Subjects who have received cosmetic treatment at the evaluation site or plan to receive it during the study period
4. Subjects who use creams, gels, all-in-one products, beauty devices, or packs on the evaluation site
5. Subjects who continuously use drugs, health foods, supplements, skin care products, cosmetics, quasi-drugs that advocate or emphasize efficacy related to the efficacy examined in this study
6. Subjects who have performed the following within the past 4 weeks or plan to do so during the study period
a) Changed or started health foods, basic cosmetics or sunscreen agents used on the evaluation sites
b) Exposed to ultraviolet rays beyond daily life
c) Participated in other human trials
d) Received a special skin care treatment on the evaluation site
7. Subjects who work night shifts or day and night shifts
8. Subjects who are undergoing treatment at medical institutions for the treatment or prevention of disease, or those who are judged to require treatment
9. Subjects with a history of serious diseases of sugar metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, psychiatric disease, alcohol or drug dependence.
10. Subjects who are at risk of developing food allergies
11. Subjects who have a smoking habit
12. Subjects who are likely to develop seasonal allergic symptoms such as hay fever and may use pharmaceuticals
13. Subjects who are pregnant, breastfeeding, or wish to become pregnant during the study period
14. Subjects who are judged by the principal investigator to be unsuitable for study participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corporation Kenshokai Fukushima Healthcare Center
Division name
Director
Zip code
553-0004
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka, Japan
TEL
06-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Okano |
Organization
CIEL CO., LTD.
Division name
CIEL CO., LTD.
Zip code
130-0021
Address
Renafine 302 ,2-10-11,Midori,Sumida-ku,Tokyo, Japan
TEL
03-6659-2767
Homepage URL
yuri.okano@ciel-tokyo.com
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
YAMASA CORPORATION
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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
DRC株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 07 | 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
36
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
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 11 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059152
