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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041618
Receipt No. R000047505
Scientific Title Inhibitory effect of the test food on ultraviolet-induced skin damage.
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/31

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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.

Condition Healthy volunteer
Classification by specialty
Classification by malignancy Others
Genomic information NO

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

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

Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Dynamic allocation
Institution consideration

No. of arms 2
Purpose of intervention Prevention
Type of intervention
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)

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

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

Institute DRC Co., Ltd.

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

Other related organizations
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

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


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

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Preinitiation
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 related information

Management information
Registered date
2020 Year 08 Month 31 Day
Last modified on
2020 Year 08 Month 31 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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