UMIN-CTR Clinical Trial

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