UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055254 |
|---|---|
| Receipt number | R000063135 |
| Scientific Title | Verification test of anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays of a supplement containing brown algae extract powder (A randomized,Double-blind,Placebo-controlled, Parallel group study) |
| Date of disclosure of the study information | 2024/08/18 |
| Last modified on | 2025/06/23 18:20:14 |
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Basic information
Public title
Verification test of anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays of a supplement containing brown algae extract powder (A randomized,Double-blind,Placebo-controlled, Parallel group study)
Acronym
Verification test of anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays of a supplement containing brown algae extract powder
Scientific Title
Verification test of anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays of a supplement containing brown algae extract powder (A randomized,Double-blind,Placebo-controlled, Parallel group study)
Scientific Title:Acronym
Verification test of anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays of a supplement containing brown algae extract powder
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the anti-glycation, anti-carbonylation and skin protection effects from ultraviolet rays by intake of a supplement containing brown algae extract powder in Japanese women aged 20 to 65 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimal Erythema Dose (MED)
Key secondary outcomes
(Secondary outcomes)
Stratum corneum moisture content,Trans-epidermal water loss,Diagnostic Imaging with VISIA,b-value (yellowish tint),Blood pentosidine (Pentosidine),Blood Carbonylated Proteins
(Safety evaluation)
Vital signs, body measurements(weight,BMI), Blood biochemistry, Hematology, Urinalysis, Adverse events
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 of the test food once a day for 12 weeks
Interventions/Control_2
Intake of the placebo food once a day for 12 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese women between the ages of 20 and 65 at the time of obtaining written consent.
2. Subjects with Fitzpatrick's Skin phototype II or III (skin phototype in which the skin turns red and then darkens when exposed to the sun for 30-45 minutes during spring and summer)
3. Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, and who voluntarily volunteer to participate in the study based on a good understanding of the purpose and content of the study, and who agree to participate in the study in writing.
Key exclusion criteria
1.Subjects who have been diagnosed by a physician as having photosensitivity, chronic dermatitis, or atopic dermatitis.
2.Subjects with a history of serious medical history or gastrointestinal resection (except for appendicectomy)
3.Subjects with illnesses that may affect testing and safety.
4.Subjects who continuously use or take anti-inflammatory drugs (topical or oral) for the skin at least once a month on the UV-exposed area (back).
5.Subjects who regularly use medicines, foods for specified health uses, health foods, etc. that may affect the examination.
6.Subjects who have developed allergies as for the foods test.
7.Subjects whose skin at the UV irradiation site (back) have factors that may affect the test results (diseases such as atopic dermatitis or urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, tattoos, or traces of such diseases).
8.Subjects who have been exposed to ultraviolet rays beyond their daily activities such as prolonged outdoor work, exercise, swimming in the sea, tanning salons, etc. in the two months prior to the primary SCR test.
9.Subjects who currently have undergone aesthetic salon, cosmetic treatment (laser treatment, etc.) or cosmetic therapy (ZEOSKIN, etc.) under the supervision of a physician on the UV-exposed area (back).
10.Subjects who plan to remove hair from the UV-irradiated area (back) during the examination period.
11.Subjects who have participated in other clinical trials or monitoring studies during the month prior to the first SCR examination, or those who plan to participate in other clinical trials during the period of this study.
12.Subjects with a current or previous history of drug or alcohol dependence.
13. Subjects who are currently visiting a hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea, etc.), or subjects who have a history of mental illness in the past.
14.Other subjects
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kasamatsu |
Organization
Kaigen Pharma Co.,Ltd.
Division name
President and Representative Director
Zip code
541-0045
Address
2-5-14, Doshomachi, Chuo-ku, Osaka, Japan
TEL
06-6202-8976
product_planning@kaigen-pharma.co.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Matsuoka |
Organization
Kaigen Pharma Co.,Ltd.
Division name
Product Development Department Product Planning Group
Zip code
541-0045
Address
2-5-14, Doshomachi, Chuo-ku, Osaka, Japan
TEL
06-6202-8976
Homepage URL
s_matsuoka@kaigen-pharma.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
Kaigen Pharma 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
Tokyo Shinjuku Clinic Ethical Review Board
Address
SIL Shinjuku 5F, 2-46-3, Kabukicho, Shinjuku-ku, Tokyo,Japan
Tel
03-6709-6071
irb@ml.taifukukai.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 18 | 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
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063135
