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	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines effects of test food on ultraviolet-induced skin damage.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MED(minimal erythema dose)
Key secondary outcomes	Transepidermal water loss Stratum corneum water content Skin color (L*, a*, b*) Photography of the irradiated area

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	Intake of test food for 12 weeks (1 capsule per day)
Interventions/Control_2	Intake of placebo food for 12 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy male and female whose age from 30 to 59 years old at the time informed consent. 2) Subjects whose Fitzpatrick skin phototype is type II or type III. 3)Subjects who accept the analysis for UV-induced erythema in their back skin. 4)Subjects whose basement MED is judged as second, third or fourth points in six-grade UV-irradiated area before intake of the test food. 5)Subjects who are aware of skin dryness and roughened. 6)Subjects who can visit to the administrative facility on every inspection day. 7)Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarity participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent.
Key exclusion criteria	1)Subjects with photosensitivity disorder. 2)Subjects who take medicine that affect light sensitivity of skin. 3)Subjects who regularly go to a dermatology office. 4)Subjects who continuously take medicine, quasi-medicine, functional food or supplement which advocate or emphasize efficacy for which is evaluated in the trial. 5)Subjects who have skin disease or abnormality such as atopic dermatitis. 6)Subjects who may perform physical activity in the sunlight for a long time during test period. 7)Subjects who take anti-inflammatory medicine at least once a month. 8)Shift worker. 9)Subjects who receive or require medical or prophylactic treatment. 10)Subjects who have a medical history for severe disease or abnormality in glucose or lipid metabolism, endocrine or nerve system, or for psychiatric disorder. 11)Subjects who have a medical history or present illness of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. 12)Subjects who have a medical history of serious gastrointestinal disease. 13)Subjects who have a medical history of alcoholism or drug addiction. 14)Subjects who have risk for allergy related to test foods. 15)Subjects who have s damage or inflammation on the measurement sites. 16)Subjects who have Severe anemia. 17)Subjects whose BMI is over 30.0 kg/m2 18)Subjects who smoke. 19)Subjects who will develop seasonal allergy symptoms like hay fever and take medicine. 20)Subjects who had been conducted an operation or beauty treatment on the measurement sites within the past 6 months. 21)Subjects who frequently intake food which might affect skin color. 22)Subjects who show abnormality in blood test during screening and test period. 23)Possible pregnancy, pregnancy and lactation 24)Subjects who were involved in another clinical studies within 4 weeks prior to the trial, or who will participate in another clinical studies. 25)Subjects who are judged to be inappropriate for the study by the principal investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name Kondo
Organization	Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name	Chairman of the Board
Zip code	553-0004
Address	2-12-13, Tamagawa, Fukushima-ku, Osaka, Japan
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	1st name Yuri Middle name Last name Okano
Organization	CIEL CO., LTD.
Division name	CIEL CO., LTD.
Zip code	130-0021
Address	Renafine 302 ,2-10-11,Midori,Sumida-ku,Tokyo, Japan
TEL	03-6659-2767
Homepage URL
Email	Yuri.okano@ciel-tokyo.com

Sponsor
Institute	DRC Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Brain Care Clinic Ethics Review Committee
Address	Isobe Build. 2F, Samon-Cho13, Shinjyuku-ku, Tokyo
Tel	06-6882-1130
Email	ethics_board@drc-web.co.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 08 Month 31 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	2020 Year 08 Month 14 Day
Date of IRB	2020 Year 08 Month 21 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 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 08 Month 31 Day
Last modified on	2021 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047505