UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028925 |
|---|---|
| Receipt number | R000033101 |
| Scientific Title | The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study |
| Date of disclosure of the study information | 2019/03/30 |
| Last modified on | 2018/09/13 12:44:23 |
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Basic information
Public title
The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study
Acronym
The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human
Scientific Title
The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study
Scientific Title:Acronym
The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test food on UV-induced skin deterioration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MED
Key secondary outcomes
Skin condition
Safety evaluation
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 for 9 weeks
Interventions/Control_2
Ingestion of placebo 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) Subjects aged from 30 to 59 years old at the time informed consent is provided.
2) Subjects whose 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.
5) Subjects who can visit to the administrative facility on every inspection day.
6) Subjects who provide the written informed consent for the involvement of this trial by themselves.
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 a functional food or a quasi-medicine which has same or similar effect with ingredient of test food
5)Subjects who continuously take medicine, quasi-medicine, functional food or supplement which advocate or emphasize efficacy for which is evaluated in the trial, or which is related to joint pain
6)Subjects who have skin disease or abnormality in skin condition such as atopic dermatitis
7)Subjects who show apparent change of skin condition that is not related to test food at the end of trial compared with the initiation
8)Subjects who take anti-inflammatory medicine at least once a month
9)Subjects who work on night shift or day and night shift
10)Subjects who receive medical or prophylactic treatment, or who require medical treatment
11)Subjects who have a past history for severe disease or abnormality in glucose or lipid metabolism, liver or kidney function, cardiovascular, respiratory, endocrine or nerve system, or for psychiatric disorder
12)Subjects who have a past history of alcoholism or drug addiction
13)Subjects who have risk for food allergy
14)Subjects who frequently intake food which is rich in same ingredient of test food, or who intake these kind of food during 3 days before and after trial initiation and last 3 days from the end of trial
15)Subjects who frequently intake food which might affect skin color
16)Subjects who show abnormality in blood test, or who are positive for HBs antigen or HCV antibody
17)Subjects who are pregnant or during lactation when the informed consent is provided, or who hope to become pregnant
18)Subjects who were involved in another trial within 4 weeks prior to the trial, or who will participate in another trial
19)Subjects who are judged to be inappropriate for the trial by the responsible doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Sumio Kondo |
Organization
Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name
Medical Corpoation Kenshokai Fukushima Healthcare Center
Zip code
Address
2-12-13, Tamagawa, Fukushima-ku, Osaka, Japan
TEL
81-(0)6-6882-1130
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Okano |
Organization
CIEL Corporation
Division name
CIEL Corporation
Zip code
Address
Renafine 302, 2-10-11, Midori, Sumida-ku, Tokyo
TEL
03-6659-2767
Homepage URL
yuri.okano@ciel-tokyo.com
Sponsor or person
Institute
DRC Corporation, Ltd.
Product Testing Department
No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
Tel: 81-(0)6-6882-1130
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM 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
Address
Tel
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
| 2019 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.mdpi.com/2072-6643/10/7/817/htm
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
| 2017 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033101
