UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000029456