UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052632 |
|---|---|
| Receipt number | R000060006 |
| Scientific Title | A study for the effect of intakes of a food ingredient on UV irradiated skin conditions in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2024/12/03 13:18:43 |
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Basic information
Public title
A study for the effects of intakes of a food ingredient on UV irradiated skin conditions in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
A study for the effect of intakes of a food ingredient on UV irradiated skin conditions
Scientific Title
A study for the effect of intakes of a food ingredient on UV irradiated skin conditions in healthy adults -Randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
A study for the effect of intakes of a food ingredient on UV irradiated skin conditions
Region
| Japan |
Condition
Condition
None (Healthy Adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a food ingredient on UV irradiated skin conditions in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (a*) on UV-irradiated site
Key secondary outcomes
Evaluation of skin condition
Blood biochemical analysis
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
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intakes of test tablets for 8 weeks
Interventions/Control_2
Intakes of placebo tablets for 8 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are between 30 and 59 years old at the time of obtaining consent
2) Subjects who are judged to be in good health and to be without any chronic physical diseases by the chief physician
3) Subjects who are concerned about decrease of moisture and elasticity with skin aging
4) Subjects who are defined skin type II or III (Japan Cosmetic Industry Association SPF Measurement Standard revised in 2007, self-report)
5) Subjects who are able to be measured UV erythema on the back skin
6) Subjects whose MED is the second, third, fourth or fifth highest irradiation energy dose
7) Subjects who are able to come to the test site on all visit dates
8) Subjects who are able to read and understand the informed consent form and able to give voluntary consent in the study
9) Subjects who are deemed appropriate to participate in the study by the chief physician.
Key exclusion criteria
Subjects
1 who are currently, or have been within the past 4 weeks, undergoing drug treatment for any disease, or who regularly use pharmaceutical or quiasi-drug products for purposes without disease treatment
2 who have been diagnosed with photosensitivity
3 who take drugs that affect the photosensitivity
4 who have any factors that may affect the results of the measurement
5 who are scheduled to undergo or have undergone within the past 4 weeks any special skincare treatment
6 who continuously use skincare products, or health foods that emphasize efficacy related to the efficacy studied in this study
7 who have changed or newly started using basic cosmetics or sunscreen products within the past 4 weeks
8 who are unable to quit the intake of supplements or health foods
9 who cannot control their intake of yogurt and intestinal preparations
10 who have been within the past 4 weeks or will be exposed to much UV radiation than they are exposed to in their daily lives
11 who are at risk of developing allergies to foods
12 who continuously use drugs for freckles, pigmentation and melasma
13 who work night shifts or day/night shifts
14 who are likely to change their lifestyle
15 who are undergoing treatment for the treatment or prevention, or who are judged to require treatment
16 who continuously use or take anti-inflammatory drugs more than once a month
17 who have a history of serious diseases (glucose metabolism, lipid metabolism, etc.)
18 who are undergoing climacteric symptom or postmenopausal hormone replacement therapy, or those who have been undergoing such therapy for at least 6 months
19 who refuse to disclose their biological sex
20 with a history of alcohol or drug dependence
21 with a smoking habit
22 who are pregnant or lactating, or those who are likely to become pregnant
23 who participate in with in the past 4 weeks or plan to participate in any other human study
24 who are jedged unsuitable as subjects by the chief physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Nozawa |
Organization
Kirin Holdings Company, Limited
Division name
Institute of Health Sciences
Zip code
251-8555
Address
Shonan Health Innovation Park, 2-26-1, Muraoka-Higashi, Fujisawa, Kanagawa, 251-8555, Japan
TEL
080-2289-3085
h-nozawa@kirin.co.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC Co., Ltd.
Division name
Product testing Department
Zip code
530-0044
Address
No9 Tabuchi Building 3F 2-10-31, Higashi tenma, Kita-ku, Osaka, 530-0044
TEL
080-0200-5022
Homepage URL
yoshida@drc-web.co.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-4128
02976_Ni@kirin.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
DRC株式会社東京評価センター（東京都）/DRC Co., Ltd. Tokyo evaluation center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060006
