UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Plant-Derived Products for Skin
Title of the study (Brief title)	Effects of Plant-Derived Products for Skin
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of a plant-derived product on female's skin condition.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Skin moisture content (Week 0, Week 6, Week 12)
Key secondary outcomes	*Secondary outcomes [1]Transepidermal water loss (Week 0, Week 6, Week 12) [2]Colour difference (Week 0, Week 6, Week 12) [3]Observation for skin condition by a specialist (Week 0, Week 6, Week 12) [4]Anti-Aging QOL Common Questionnaire (Week 0, Week 6, Week 12) [5]Profile of Mood States Japanese Version (Week 0, Week 6, Week 12) [6]Visual Analogue Scale (Week 0, Week 6, Week 12) *Safety [1]Diagnosis by doctors (Week 0, Week 6, Week 12) *Other outcomes [1]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

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	Oral intake of the test product (8g in a day; 12 weeks)
Interventions/Control_2	Oral intake of the placebo product (8g in a day; 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Female
Key inclusion criteria	[1]Females aged 30-59 years [2]Individuals who are healthy and have no chronic physical disease including skin disease [3]Individuals who are concerning on dry skin [4]Individuals whose written informed consent has been obtained [5]Individuals who can have an examination in a designated day [6]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals with skin disease, such as atopic dermatitis [3]Individuals with strange skin conditions at measurement points [4]Individuals who used or applied a drug for treatment of disease in the past 1 month [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease [6]Individuals who contract or have a history of serious gastrointestinal disease [7]Individuals with serious anemia [8]Individuals who have milk allergy [9]Individuals who are sensitive to test product or other foods, and medical products [10]Individuals who are or are possibly pregnant, or are lactating [11]Individuals who have an addiction to alcohol or a mental illness [12]Individuals who are a smoker [13]Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period [14]Individuals with probable seasonal allergy, such as pollinosis, during the test period [15]Individuals who are busy to their own work, housework or child care and neglect skin care [16]Individuals who cannot avoid daylight exposure during the test period [17]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period [18]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months [19]Individuals who had been conducted an operation on the test spot [20]Individuals who had been conducted an operation on the test spot [21]Individuals who participated in other clinical studies in the past 3 months [22]Individuals judged inappropriate for the study by the principal
Target sample size	44

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Director
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-6801-8480
Email	info@tes-h.co.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd
Division name	Department of Development for Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	t.tamura@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	Yakult Health Foods Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 25 Day
Last modified on	2017 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028704