UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of effectiveness to skin condition of women by oral consumption of the food which contain black tea fragrance.
Acronym	Study of effectiveness to skin condition of women by consumption of the black tea fragrance containing food.
Scientific Title	A verification study of effectiveness to skin condition of women by oral consumption of the food which contain black tea fragrance.
Scientific Title:Acronym	Study of effectiveness to skin condition of women by consumption of the black tea fragrance containing food.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the influence to skin condition of women by oral consumption of black tea fragrance containing food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Moisture content of Stratum Corneum *Transepidermal Water Loss(TEWL) *Viscoelasticity of the skin *Skin color *VISIA's indicators(pores, spots, wrinkles, texture, red areas, UV spots, porphyrins, brown spots) *Blood flow *Skin temperature *Brain stress *Stabilometry *Questionnaire *Vascular age
Key secondary outcomes	* Incidence of adverse events * Incidence of side effects

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	During in first period, intake one tablet of test food at once, four times a day for three weeks. And during in second period, intake one tablet of control food at once, four times a day for three weeks. No washout period is prepared.
Interventions/Control_2	During in first period, intake one tablet of control food at once, four times a day for three weeks. And during in second period, intake one tablet of test food at once, four times a day for three weeks. No washout period is prepared.
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	25 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	(1) Females aged 25 to 39 years old. (2) Subjects who recognize stress and dryness of their skin as subjective symptoms. (3) Subjects who use more than two kind of cosmetics in order to skin care on a daily basis. (4) Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent.
Key exclusion criteria	(1) Subjects who are currently receiving medication due to treatment of disease. (2) Subjects who have smoking habit. (3) Subjects who are treated hormone therapy. (4) Subjects who have symptom of rhinitis during test period. (5) Subjects who consume medicines, foods for specified health use, functional foods, supplements and/or health foods which may affect their skin quality more than three times a week. (6) Subjects who plan to go long travel during test period. (7) Subjects who can't do UV care when they go out during test period. (8) Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer) (9) Subjects who have symptom of dermatologic disease such as atopic dermatitis. (10) Subjects who have undergone surgery on investigation objective portion within the past 6 months. (11) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within a month prior to the current study. (12) Subjects who themselves and/or their family are working for a company that develops, manufactures or sells health / functional foods and cosmetics. (13) Subjects who dislike black tea fragrance. (14) Pregnant or expected pregnant, or lactating women. (15) Others who have been determined ineligible by investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Yukihiro Middle name Last name Yada
Organization	University of Tsukuba School of Integrative
Division name	Global Majors
Zip code	305-8577
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL	029-853-7344
Email	yada.yukihiri.gb@u.tsukuba.ac.jp

Public contact
Name of contact person	1st name Miyuki Middle name Last name Fujishiro
Organization	COSMOS TECHNICAL CENTER CO.,LTD.
Division name	Department of Efficacy and Safety Evaluation
Zip code	174-0046
Address	3-24-3 Hasune Itabashi-ku, Tokyo 174-0046, Japan
TEL	03-3966-7755
Homepage URL
Email	fujishiro@ns-cosmos.co.jp

Sponsor
Institute	COSMOS TECHNICAL CENTER CO., LTD.
Institute
Department

Funding Source
Organization	Mitsui Norin 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.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	2019 Year 02 Month 22 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	Completed
Date of protocol fixation	2019 Year 02 Month 15 Day
Date of IRB	2019 Year 02 Month 15 Day
Anticipated trial start date	2019 Year 02 Month 22 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 19 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040939