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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042220
Receipt No. 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 2020/10/07

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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
Email 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
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

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
Email 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
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
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
2020 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047979

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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