UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041618 |
|---|---|
| Receipt number | 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 | 2021/03/01 09:07:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Yuri.okano@ciel-tokyo.com
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047505
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
