UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046791 |
|---|---|
| Receipt number | R000053309 |
| Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group study of the skin-protective effects of crocetin against UV exposure |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/08/03 09:36:20 |
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Basic information
Public title
Evaluation of the protective effect of crocetin on skin against UV exposure
Acronym
Evaluation of the protective effect of crocetin on skin against UV exposure
Scientific Title
A randomized, placebo-controlled, double-blind, parallel-group study of the skin-protective effects of crocetin against UV exposure
Scientific Title:Acronym
A randomized, placebo-controlled, double-blind, parallel-group study of the skin-protective effects of crocetin against UV exposure
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of test food intake on UV-induced skin deterioration in healthy adult Japanese men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimal erythema dose
Key secondary outcomes
Skin condition [transepidermal water loss, stratum corneum water content, skin color(L*, a*, b*), roughness (Ra) analysis by ntera3D, photography of irradiated area]
Quantification of IL-1alpha and IL-1RA using tape strips
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 period: 5 weeks
Test food: Soft capsule containing crocetin (7.5 mg)
Once a day (1 capsule/day)
Interventions/Control_2
Intake period: 5 weeks
Test food: Placebo soft capsule
Once a day (1 capsule/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 adult males and females between the ages of 30 and 60 years at the time of consent
2. have a Fitzpatrick skin phototype of type II or III
3. Participants whose dorsal skin can be determined to have UV erythema.
4. Participants who were judged to have MED in the second, third, or fourth of the six levels of UV radiation at the time of MED judgment before ingestion of the test product (Day 1).
5. Participants who be able to visit the test site on all test days
6. Those who can provide written consent to participate in the study voluntarily
Key exclusion criteria
1. smoker
2. patients with a history of atopic dermatitis or a predisposition to atopy
3. those who have factors on the skin of the evaluation site that may affect the results of the test
4. those who have been diagnosed as photosensitive
5. those who have undergone or will undergo cosmetic procedures on the evaluation site
6. those who have undergone any special skin care treatment within the past 4 weeks, or plan to do so during the examination period
7. participants who have continuously used skin care products or health foods that advocate or emphasize efficacy similar to or related to the efficacy to be studied in this study
8. those who have changed or newly started using health food products or basic cosmetics or sunscreen products within the past four weeks
9. those who have been or will be exposed to ultraviolet radiation beyond their daily activities within the past 4 weeks
10. those who may be allergic to food
11. those who have been taking medicines which are indicated for the treatment of freckles, pigmentation due to sunburn, and melasma
12. those who work night shifts or day/night shifts
13. those who are undergoing medical treatment for the treatment or prevention of disease at the time of obtaining consent, or those who are judged to be in need of treatment
14. those who are taking drugs that affect the photosensitivity of the skin
15. those who continuously use or take anti-inflammatory drugs at least once a month
16. participants who had a history of serious diseases.
17. undergoing hormone replacement therapy for menopause or postmenopausal women, or those who have not been under treatment for at least 6 months
18. those with a history of alcohol or drug dependence.
19. pregnant or lactating at the time of consent, or who wish to become pregnant during the study period
20. those who have participated in other human studies within the past 4 weeks
21. those who are judged as unsuitable to participate in the study by the principal investigator
Target sample size
50
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
Chief of a 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 | Naofumi |
| Middle name | |
| Last name | UMIGAI |
Organization
RIKEN VITAMIN CO., LTD.
Division name
Healthcare unit
Zip code
160-0004
Address
1-6-1 Yotsuya, Shinjuku-ku, Tokyo, Japan
TEL
03-5362-1334
Homepage URL
nao_umigai@rike-vita.co.jp
Sponsor or person
Institute
RIKEN VITAMIN CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
RIKEN VITAMIN 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 Ethical Review Board
Address
2-1-2 Shinjuku, Shinjuku-ku, Tokyo, Japan
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
DCR株式会社 評価センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
54
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 | 01 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 07 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053309
