UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049002 |
|---|---|
| Receipt number | R000055823 |
| Scientific Title | The inhibitory effect on ultraviolet-induced skin damage by long-term use of test food. |
| Date of disclosure of the study information | 2023/08/26 |
| Last modified on | 2023/09/26 17:05:35 |
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Basic information
Public title
The inhibitory effect on ultraviolet-induced skin damage by long-term use of test food.
Acronym
The inhibitory effect on ultraviolet-induced skin damage by long-term use of test food.
Scientific Title
The inhibitory effect on ultraviolet-induced skin damage by long-term use of test food.
Scientific Title:Acronym
The inhibitory effect on ultraviolet-induced skin damage by long-term use of test food.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | 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
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimal erythema dose (MED)
Evaluate before and 8 weeks after intake.
Key secondary outcomes
Skin color (L*, a*, b*);
Evaluate before, 8 weeks and 9 weeks after intake.
photography of irradiated area;
Evaluate before, 8 weeks and 9 weeks after intake.
blood pentosidine;
Evaluate before and 9 weeks after intake.
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
Ingestion of test food (tablets that contain phycocyanin) for 9 weeks
Interventions/Control_2
Ingestion of placebo (tablets that don't contain phycocyanin) for 9 weeks
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 aged between 30 and 60 at the time of informed consent
2. Subjects whose Fitzpatrick skin phototype is type II or type III
3. Subjects whose dorsal skin can be determined to have UV erythema
4. Subjects who were judged to have MED in the second, third, fourth, fifth of the six levels of UV radiation at the time of MED judgment before ingestion of the test product (Day 1)
5. Subjects who be able to visit the test site on all test days
6. Subjects who can provide written consent to participate in the study voluntarily
Key exclusion criteria
1. Subjects who have symptoms of skin diseases on the evaluation site which may affect the test results
2. Subjects with photosensitivity disorder
3. Subjects who continuously take a functional food or quasi-medicine which has same or similar effect with active ingredient of test food
4. Subjects who got some cosmetic surgery, or hormone therapy which would affect the target skins, or plan to do so during the examination period
5. Subjects who have undergone any special skin care treatment within the past 4 weeks, or plan to do so during the examination period
6. Subjects who use pharmaceuticals and quasi-drugs effective in the treatment of UV-induced skin pigmentation and chloasma
7. Subjects who have risk for allergy related to test foods
8. Subjects who plan to have ultraviolet exposure within a month before the screening test
9. Shift workers
10. Subjects who are undergoing medical treatment or who requires medical or prophylactic treatment at the time of informed consent
11. Subjects who take medicine that affect light sensitivity of skin
12. Subjects taking anti-inflammatory medicine at least once a month, or who are planning to take them during the study period
13. Subjects who have a medical history for severe disease or abnormality in glucose or lipid metabolism, endocrine or nerve system, or for psychiatric disorder
14. Subjects who have a medical history or present illness of serious hepatopathy, kidney damage, heart disease, hematological and blood disease
15. Subjects who have a medical history of alcoholism or drug addiction
16. Subjects who are pregnant or lactating, or who intend to become pregnant
17. Subjects who were involved in another clinical studies within 4 weeks prior to the trial, or who will participate in another clinical studies
18. Subjects who have changed and/or started using functional foods and/or sunscreen on the target area within 4 weeks.
19. Subjects who are judged as unsuitable participant by the doctor for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Kondo |
Organization
Medical Corporation Kenshokai
Division name
Fukushima Healthcare Center
Zip code
553-0004
Address
2-12-16, Tamagawa Fukushima-ku, Osaka, Japan
TEL
06-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Naganuma |
Organization
DRC Co., Ltd.
Division name
Product Testing Department
Zip code
530-0044
Address
No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
TEL
06-6882-1130
Homepage URL
naganuma@drc-web.co.jp
Sponsor or person
Institute
DRC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DIC Corporation
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
Hakucho Build 2F, 2-1-2 Shinjyuku, 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
| 2023 | Year | 08 | Month | 26 | 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
| 2022 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055823
