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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025593
Receipt No. 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

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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
Email 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
Email makoto.tsunenaga@to.shiseido.co.jp

Sponsor
Institute Shiseido Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029456

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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