UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025593 |
|---|---|
| Receipt number | R000029456 |
| Scientific Title | Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect (Randomized, double-blind, placebo-controlled, parallel-group study) |
| Date of disclosure of the study information | 2017/01/12 |
| Last modified on | 2019/05/31 09:59:18 |
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Basic information
Public title
Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect
(Randomized, double-blind, placebo-controlled, parallel-group study)
Acronym
Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect
Scientific Title
Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect
(Randomized, double-blind, placebo-controlled, parallel-group study)
Scientific Title:Acronym
Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the prevention of UV-induced inflammation after the consumption of a test food in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (L*, a*, erythema index, melanin index) on the UV-irradiated region after 1.5 MED UV irradiation at 0, 8 weeks after the intake
Key secondary outcomes
Minimal Erythema Dose
Minimal Tanning Dose
Skin color (L*, a*)
Stratum corneum hydration
Transepidermal water loss
changes of anti-oxidants in serum
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
test food (6 tablets once a day for nine weeks)
Interventions/Control_2
Placebo food (6 tablets once a day for five 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person who is a healthy person who does not fall under the following exclusion criteria and whose age at the time of consent acquisition date is from 20 years old to under 59 years old and who give written informed consent
1) Subjects without apparent pigmentation, inflammation, and other abnormalities at the test site
2) Subjects whose skin will sunburn (form erythema) easily and does not develop a tan by UV irradiation (Fizpatrick skin type I or II)
3) Subjects who has a relatively low daily intake of goji berry, tea with whitening effect
4) Subjects who are judged as suitable for the study by the investigator
Key exclusion criteria
1) Subjects with apparent pigmentation, inflammation, and other significant abnormalities at the test site
2) Subjects with history of photo sensitivity
3) Subjects with risk of allergy regarding to test food
4) Subjects who have excessive sunburn in 3 months
5) Subjects who have chronic skin symptoms such as atopic dermatitis at the test site
6) Subjects who is in pregnancy, or plan to get pregnant during this study period
7) Subjects who have chronic diseases such as asthma and who regularly use drugs
8) Subjects who presently take medications that are effective for liver spots, spots, freckles and pigmentation due to sunburns, such as L-cysteine-containing drugs, vitamin-C-containing drugs and tranexamic acid-containing drugs that are thought to affect the evaluation
9) Subjects who used supplements for cosmetic (especially whitening) supplements for more than 5 days a week within past 3 months (products that prompted antioxidant action such as catechin, flavonoids and high content of polyphenols)
10) Subjects who have participated in other clinical trials within the past 3 months, or who plan to participate
11) Subjects with smoking habit
12) Subjects who used external use medicine to the test site within past one week
13) Subjects who have a plan to go abroad, sea bathing, etc. during the study period
14) Subjects who has receiving menopausal disorder and postmenopausal "hormone replacement therapy"
15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Ueda |
Organization
Shiseido Co., Ltd.
Division name
Advanced Research Center
Zip code
220-0011
Address
2-2-1, Hayabuchi, Tsuzuki-ku, Yokohama, Kanagawa, 224-8558 Japan
TEL
045-590-6000
osamu.ueda@to.shiseido.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Tsunenaga |
Organization
Shiseido Co., Ltd.
Division name
Advanced Research Center
Zip code
220-0011
Address
2-2-1, Hayabuchi, Tsuzuki-ku, Yokohama, Kanagawa, 224-8558 Japan
TEL
045-590-6000
Homepage URL
makoto.tsunenaga@to.shiseido.co.jp
Sponsor or person
Institute
Shiseido Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
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
NPO corporation Hokkaido activation center TACTICS Ethics Committee
Address
Hokkaido 2-Chome Chuo-ku Kita 2-jo 9-chome Infas NPO corporation Hokkaido Activation Center TACTICS Ethics Committee Secretariat
Tel
011-281-6783
iwasaki@muramatsu-law-office.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
| 2017 | Year | 01 | Month | 12 | 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
| 2016 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 19 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029456
