UMIN-CTR Clinical Trial

Basic information
Public title	A study for skin condition by intake a food to be examined by UV irradiation. -A placebo-controlled, randomized, double-blind, cross-over trial-
Acronym	A study for skin condition by intake a food to be examined by UV irradiation.
Scientific Title	A study for skin condition by intake a food to be examined by UV irradiation. -A placebo-controlled, randomized, double-blind, cross-over trial-
Scientific Title:Acronym	A study for skin condition by intake a food to be examined by UV irradiation.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider the effect of taking test food capsules for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks, on skin color and moisturizing after MED irradiation in comparison with control foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. MED judgment by the responsible or assigned doctor. 2. Stratum corneum moisture content. 3. Skin viscoelasticity.
Key secondary outcomes	Conduct VAS on the skin every week during the intake period (9 times in total) for: Skin viscoelasticity, Skin clarity, Youthfulness (visual impression), Improvement of rough skin, Improvement of fine wrinkles, improvement of dull skin, Improvement of laugh line.

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	Treatment
Type of intervention	Food
Interventions/Control_1	Take 1 capsule of test food three times a day after breakfast, lunch, and dinner for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks. Do not take two capsules at once if it was forgotten to take.
Interventions/Control_2	Take 1 capsule of control food three times a day after breakfast, lunch, and dinner for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks. Do not take two capsules at once if it was forgotten to take.
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	30 years-old <=
Age-upper limit	45 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Male and female from 30 to 45 years old with no skin disorders. (2) Subjects with BMI of 18.5 or more and less than 30. (3) Subjects whose skin photo type is Type I or II (4) Subjects who can judge UV erythema on the inner skin of the upper arm. (5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects who have been diagnosed with photosensitivity. (2) Subjects taking drugs that affect skin photosensitivity. (3) Subjects who are currently visiting a dermatologist or are being treated for other diseases. (4) Subjects with a history of sugar metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular, respiratory and endocrine systems. (5) Subjects who regularly take medicines or health foods that are said to have moisturizing and whitening effects. (6) Subjects with symptoms of atopic dermatitis. (7) Subjects with significant abnormal skin condition at the test site, or subjects with sunburn. (8) Subjects with severe hay fever symptoms. (9) Subjects who continuously use or take anti-inflammatory drugs at least once a month. (10) Subjects who are using or taking drugs such as oral or liniment because of rough skin. (11) Subjects with food allergies to olive-containing foods. (12) Night shift worker or day and night shift workers. (13) Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption. (14) Subjects who are judged to be inappropriate as subjects from the answers to the subject background questionnaire. (15) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. (16) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence. (17) Subjects who have participated in similar UV irradiation studies within the last two years. (18) Subjects who participate in other human studies within the last 4 weeks or who plan to participate in other human studied during the period of this study. (19) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Kayoko Middle name Last name Numano
Organization	NUMANO CLINIC
Division name	Dermatology
Zip code	150-0013
Address	1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL	03-5793-8712
Email	kaco121@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Komori
Organization	KSO Corporation
Division name	Sales Department
Zip code	105-0023
Address	7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	MITSUBISHI-CHEMICAL FOODS CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	General Incorporated Association Clinical Research Review Centers
Address	2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.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	2020 Year 01 Month 09 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	28
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 12 Month 02 Day
Date of IRB	2019 Year 12 Month 11 Day
Anticipated trial start date	2020 Year 01 Month 10 Day
Last follow-up date	2020 Year 03 Month 29 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 01 Month 08 Day
Last modified on	2020 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044575