UMIN-CTR Clinical Trial

Basic information
Public title	Inhibitory effect of the test food on ultraviolet-induced skin damage.
Acronym	Inhibitory effect of the test food on ultraviolet-induced skin damage.
Scientific Title	Inhibitory effect of the test food on ultraviolet-induced skin damage.
Scientific Title:Acronym	Inhibitory effect of the test food on ultraviolet-induced skin damage.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the protective effect of UV skin damage by ingesting test food.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The measured values of Minimal Erythema Dose (MED) at 8 weeks after the start of test-food consumption
Key secondary outcomes	1. The measured values of Minimal Erythema Dose (MED) at 4 weeks after the start of test-food consumption 2. The amount of changes of the measured values of MED between screening and at four and eight weeks after the start of test-food consumption. 3. The measured values of moisture of the skin, transepidermal water loss (TEWL), melanin index, erythema index, skin color (L*, a*, b*), minimal tanning dose (MTD) at four and eight weeks after the start of test-food consumption. 4. The amount of changes of the measured values of moisture of the skin, TEWL, melanin index, erythema index, skin color (L*, a*, b*), MTD at four and eight weeks after the start of test-food consumption. 5. The measured values of the questionnaire at four and eight weeks after the start of test-food consumption.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food for 8 weeks (1 capsule per day)
Interventions/Control_2	Intake of placebo food for 8 weeks (1 capsule per day)
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	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy male and female aged from 20 to 59 years old at the time informed consent. 2) Subjects with fair or normal skin color 3) Subjects who are aware of skin roughened. 4) Subjects who can agree that circular sunburn marks (up to 12 on each side) will remain on the medial side of the upper arm for about half a year (depending on the skin type) 5) Subjects who are able to confirm 1 MED in any of the 6 irradiation fields by MED judgment. However, if the number of subjects who meet the conditions exceeds the number to be selected, the subjects who can confirm 1 MED with a smaller irradiation energy will be selected. 6) Subjects whose TEWL of inside the right forearm is relatively high at screening 7) Subjects who are healthy and have no problem in participating in the study judged by a doctor
Key exclusion criteria	1) Subjects who may exhibit skin allergic symptoms or with skin hypersensitivity 2) Subjects who may show allergic symptoms due to the ingredients of the test product 3) Subjects undergoing hospital visits, medications, and treatment 4) Subjects who are pregnant, potentially pregnant or lactating 5) Subjects participating in other clinical trials 6) Subjects with chronic diseases or disorders of the liver / biliary tract / digestive system, circulatory / respiratory system, renal / urinary system, psychiatric / nervous system, blood system 7) Subjects with a history or present illness of hepatitis 8) Subjects whose lifestyle may change significantly during the test period (including overseas travel) 9) Subjects who continuously take functional foods and supplements that may affect test results (anti-inflammatory, whitening, skin turnover, etc.) 10) Subjects with UV damage, pigmentation (stains), skin diseases, etc. on the medial side of the left and right forearms 11) Subjects who have blisters due to sunburn 12) Subject with extremely thin upper arm 13) Subjects who are in a situation where sunburn is unavoidable due to long hours of outdoor work or sports from screening to the end of the test 14) Subjects who are smoker 15) Subjects who have been exposed to artificial UV radiation within the last two months
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	105-0013
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1599
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Kaneko Middle name Last name Miwa
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	105-0013
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	m_kaneko@mail.souken-r.com

Sponsor
Institute	SOUKEN Co., Ltd
Institute
Department

Funding Source
Organization	ORYZA OIL & FAT CHEMICAL Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Shiba Palace Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1599
Email	jimukyoku@mail.souken-r.com

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	2021 Year 07 Month 30 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 10 Day
Date of IRB	2020 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 12 Month 14 Day
Last follow-up date	2021 Year 04 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 09 Day
Last modified on	2020 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048728