UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Effect of Plant-Derived Products on skin function
Acronym	A Study on the Effect of Plant-Derived Products on skin function
Scientific Title	A Study on the Effect of Plant-Derived Products on skin function
Scientific Title:Acronym	A Study on the Effect of Plant-Derived Products on skin function
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of plant-derived products on skin function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin moisture content
Key secondary outcomes	Transepidermal water loss Skin viscoelasticity Observation for skin condition by dermatologists Questionnaire survey (Visual Analogue Scale) on the physical condition

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	Plant-Derived Products, 8 weeks consumption
Interventions/Control_2	Placebo Products, 8 weeks consumption
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)Females aged 35-49 years. 2)Subjects who are healthy and are not suffered from chronic disease including skin disease. 3)Subjects who are aware of skin dryness. 4)Subjects who can make self-judgment and are voluntarily giving written informed consent. 5)Subjects who can have an examination on a designated check day. 6)Subjects who are judged as suitable for the current study by the investigator.
Key exclusion criteria	Subjects (who) 1)contract disease and are under treatment. 2)with skin disease, such as atopic dermatitis. 3)with strange skin conditions at measurement points. 4)used a drug to treat a disease in the past 1 month. 5)used antibiotics within the last 2 weeks prior to the screening and pre-intake test. 6)have a history of and/or contract serious diseases (eg, liver disease, kidney disease, heart disease, lung disease, blood disease). 7)have a history and/or contract digestive disease. 8)with serious anemia. 9)whose BMI are 30 or more. 10)have allergic reaction to ingredients of test foods and other foods or drugs. 11)have a habit to use drugs claiming to improve skin function in the past 3 months. 12)have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve skin function in the past 3 months and/or are planning to use those foods during test periods. 13)have a habit to take foods related to green juice in the past 3 months and/or are planning to use those foods during test periods. 14)regularly take foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or viable bacteria. 15)are or are possibly pregnant, or are lactating. 16)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent. 17)with psychiatric disease. 18)are smokers. 19)with possible changes of life style during test periods. 20)will develop seasonal allergy symptoms, such as pollinosis, eye and nose symptoms and/or use an anti-allergic drug. 21)neglect skin care. 22)can't avoid direct sunlight exposure, such as sunburn, during test periods. 23)had been conducted an operation or beauty treatment on the test spot in the past 6 months. 24)are participating and/or had participated in other clinical studies within the last 3 months. 25)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinic

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	TOYO SHINYAKU 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.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	2021 Year 01 Month 20 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049165
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/49100/1689
Number of participants that the trial has enrolled	50
Results	Statistically significant difference was confirmed in the primary outcome.
Results date posted	2021 Year 12 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Females aged 35 to 49 years old.
Participant flow	Enrolled(n=50) Completed(n=49) Analysed(n=39)
Adverse events	No adverse events were observed that be related to test food.
Outcome measures	Skin moisture content
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 12 Month 09 Day
Date of IRB	2020 Year 12 Month 10 Day
Anticipated trial start date	2021 Year 01 Month 21 Day
Last follow-up date	2021 Year 04 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 20 Day
Last modified on	2021 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049165