UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042220 |
|---|---|
| Receipt number | R000047979 |
| Scientific Title | Evaluation study for intake of test food containing plant extract on effect in skin moisture |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/01/22 19:51:45 |
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Basic information
Public title
Evaluation study for intake of test food containing plant extract on effect in skin moisture
Acronym
Evaluation study for intake of test food containing plant extract on effect in skin moisture
Scientific Title
Evaluation study for intake of test food containing plant extract on effect in skin moisture
Scientific Title:Acronym
Evaluation study for intake of test food containing plant extract on effect in skin moisture
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effect in skin moisture by taking the test food containing plant extract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transepidermal water loss (0-4-8-12w)
Key secondary outcomes
skin hydration
skin elasticity
skin color difference
Image analysis by VISIA
AGEs reader
Anti-Aging QOL Common Questionnaire
blood test
urine test
body height
body mass and BMI
blood pressure, pulsation
subjects'diary
doctor's questions
VAS questionnaire
(0-4-8-12w)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake the active food for 12 weeks
Interventions/Control_2
Intake the placebo food 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20 to 64 years old
2) Subjects who are concerned about their sagging skin
3) Subjects who are concerned about their skin wrinkles
4) Subjects who are concerned about their dry skin
5) Subjects who are conscious of skin symptoms caused by dry skin on their right cheeks, right necks, upper backs, right shins, right dorsums of feet or lower right inner arms every year from December to March.
6) Subjects who can refrain from drinking from the day before each measurement until the day of each measurement
Key exclusion criteria
1) Subjects who are taking medicines that can affect the test result
2) Subjects with chronic skin symptoms such as atopic dermatitis
3) Subjects who are using cosmetics containing hyaluronic acid, collagen, ceramide or vitamins or have used them within 1 month before the test
4) Subjects with histories of severe liver disorder, renal disorder or heart disease
5) Subjects with severe anemia
6) Subjects who are taking or plan to take medicines due to hay fever
7) Subjects who are currently attending dermatology
8) Subjects who are participating in other clinical trials or have participated in them within 3 months before the test
9) Subjects who are participating in other clinical trials
10) Subjects who are pregnant, breast-feeding or have possibility (hope) of pregnancy
11) Subjects who have sensitive skin or are allergic to the test product
12) Subjects who are allergic to the test product
13) Subjects with significant abnormality in skin conditions on their test sites
14) Subjects who have chronic illness and take drugs regularly
15) Subjects with asthma
16) Subjects who are taking medicines for skin such as L-cysteine and vitamins or have taken them within 1 month before the test
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1590
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Ko |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
Funding Source
Organization
Ortho Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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
| 2020 | Year | 12 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 23 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047979
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| Registered date | File name |
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