UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053035 |
|---|---|
| Receipt number | R000060509 |
| Scientific Title | A verification study of the anti-ultraviolet light effects of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2023/12/08 |
| Last modified on | 2024/10/07 16:08:12 |
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Basic information
Public title
A verification study of the anti-ultraviolet light effects of the test food
Acronym
A verification study of the anti-ultraviolet light effects of the test food
Scientific Title
A verification study of the anti-ultraviolet light effects of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
A verification study of the anti-ultraviolet light effects of the test food
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the anti-ultraviolet light effects of the test food consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of minimum erythema dose (MED) at eight weeks after consumption (8w)
Key secondary outcomes
1. The measured values of skin tone (L*-value, a*-value, b*-value), transepidermal water loss, skin moisture content, and viscoelasticity of skin at 8w
2. The measured value of original questionnaire at 8w
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: Eight weeks
Test food: Active food 1
Interventions/Control_2
Duration: Eight weeks
Test food: Placebo food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who have skin type II or III on the Fitzpatrick Scale
6. Individuals who have relatively low MED at screening (before consumption) among those who met the inclusion criteria No. 1~5
Key exclusion criteria
Individuals (who)
1. are undergoing treatment or have a history of malignant tumor (including skin cancer), heart failure, myocardial infarction, or atopic dermatitis
2. have a pacemaker or an implantable cardioverter defibrillator
3. under treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. take "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. take medications, herbal medicines, or supplements
6. are allergic to medicines, the test food related products, and/or crustaceans
7. engage in occupations involving outdoor work
8. plan outings or other activities, such as swimming in the sea, mountain climbing, or winter sports, involving a lot of sunlight during the study
9. use or practice daily skincare (e.g., body scrub, strigilation) except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, skin lotions, face masks, milky lotions, and sunscreen
10. habitually receive skincare treatment (e.g., aesthetic treatment, massage) or use instruments for beauty treatment (e.g., facial treatment device)
11. have skin which always reddens and never darkens after sun exposure or tanning salon treatment, or have been pointed out by a third party for that
12. have developed urticaria after sun exposure or tanning salon treatment, or have been pointed out by a third party for that
13. are exposed to ultraviolet light (UV) daily (e.g., arc welding and fusing work, work under UV sterilization light, genetic testing work)
14. with art makeup or tattoos
15. are pregnant, lactating, or planning to become pregnant during the study
16. have been enrolled in other clinical studies within the last 28 days before the agreement to participate or plan to participate another study during the study
17. are judged as ineligible to participate in the study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Izumi |
Organization
Hiroo Dermatology Clinic & Mentors inc.
Division name
Director
Zip code
150-0012
Address
1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
03-5795-1112
dr_izumi@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
BGG Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hiroo Dermatology Clinic & Mentors inc.
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.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
広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 08 | 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
44
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 | 10 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 10 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060509
