UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042696 |
|---|---|
| Receipt number | R000048728 |
| Scientific Title | Inhibitory effect of the test food on ultraviolet-induced skin damage. |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2020/12/09 10:19:00 |
* 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
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the protective effect of UV skin damage by ingesting test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The measured values of Minimal Erythema Dose (MED) at 8 weeks after the start of test-food consumption
Key secondary outcomes
1. The measured values of Minimal Erythema Dose (MED) at 4 weeks after the start of test-food consumption
2. The amount of changes of the measured values of MED between screening and at four and eight weeks after the start of test-food consumption.
3. The measured values of moisture of the skin, transepidermal water loss (TEWL), melanin index, erythema index, skin color (L*, a*, b*), minimal tanning dose (MTD) at four and eight weeks after the start of test-food consumption.
4. The amount of changes of the measured values of moisture of the skin, TEWL, melanin index, erythema index, skin color (L*, a*, b*), MTD at four and eight weeks after the start of test-food consumption.
5. The measured values of the questionnaire at four and eight weeks after the start of test-food consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 weeks (1 capsule per day)
Interventions/Control_2
Intake of placebo food for 8 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy male and female aged from 20 to 59 years old at the time informed consent.
2) Subjects with fair or normal skin color
3) Subjects who are aware of skin roughened.
4) Subjects who can agree that circular sunburn marks (up to 12 on each side) will remain on the medial side of the upper arm for about half a year (depending on the skin type)
5) Subjects who are able to confirm 1 MED in any of the 6 irradiation fields by MED judgment.
However, if the number of subjects who meet the conditions exceeds the number to be selected, the subjects who can confirm 1 MED with a smaller irradiation energy will be selected.
6) Subjects whose TEWL of inside the right forearm is relatively high at screening
7) Subjects who are healthy and have no problem in participating in the study judged by a doctor
Key exclusion criteria
1) Subjects who may exhibit skin allergic symptoms or with skin hypersensitivity
2) Subjects who may show allergic symptoms due to the ingredients of the test product
3) Subjects undergoing hospital visits, medications, and treatment
4) Subjects who are pregnant, potentially pregnant or lactating
5) Subjects participating in other clinical trials
6) Subjects with chronic diseases or disorders of the liver / biliary tract / digestive system, circulatory / respiratory system, renal / urinary system, psychiatric / nervous system, blood system
7) Subjects with a history or present illness of hepatitis
8) Subjects whose lifestyle may change significantly during the test period (including overseas travel)
9) Subjects who continuously take functional foods and supplements that may affect test results (anti-inflammatory, whitening, skin turnover, etc.)
10) Subjects with UV damage, pigmentation (stains), skin diseases, etc. on the medial side of the left and right forearms
11) Subjects who have blisters due to sunburn
12) Subject with extremely thin upper arm
13) Subjects who are in a situation where sunburn is unavoidable due to long hours of outdoor work or sports from screening to the end of the test
14) Subjects who are smoker
15) Subjects who have been exposed to artificial UV radiation within the last two months
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Chair
Zip code
105-0013
Address
6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Kaneko |
| Middle name | |
| Last name | Miwa |
Organization
SOUKEN Co., Ltd
Division name
Management Division
Zip code
105-0013
Address
3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL
03-5408-1555
Homepage URL
m_kaneko@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
ORYZA OIL & FAT CHEMICAL Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiba Palace Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2021 | Year | 07 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 08 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048728
