UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035937 |
|---|---|
| Receipt number | R000040939 |
| Scientific Title | A verification study of effectiveness to skin condition of women by oral consumption of the food which contain black tea fragrance. |
| Date of disclosure of the study information | 2019/02/22 |
| Last modified on | 2020/10/09 11:46:23 |
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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
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
fujishiro@ns-cosmos.co.jp
Sponsor or person
Institute
COSMOS TECHNICAL CENTER CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040939
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