UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055048 |
|---|---|
| Receipt number | R000062887 |
| Scientific Title | A systematic review of the skin moisturizing effects of Astaxanthin. |
| Date of disclosure of the study information | 2024/07/23 |
| Last modified on | 2024/07/23 11:16:26 |
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Basic information
Public title
A systematic review of the skin moisturizing effects of Astaxanthin.
Acronym
A systematic review of the skin moisturizing effects of Astaxanthin.
Scientific Title
A systematic review of the skin moisturizing effects of Astaxanthin.
Scientific Title:Acronym
A systematic review of the skin moisturizing effects of Astaxanthin.
Region
| Japan |
Condition
Condition
Persons not suffering from any disease (excluding persons under 18 years of age, pregnant or nursing mothers)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of astaxanthin intake on skin moisture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome will evaluate the ability to help protect skin moisture. The effect on skin moisture will be evaluated. Specifically, Skin moisture content and Transepidermal water loss are used as endpoints, and both outcomes will be evaluated comprehensively.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
A systematic literature search is performed through scientific and clinical trial registries databases.
The selection criteria are as follows.
P-Persons not suffering from any disease (excluding persons under 18 years of age, pregnant or nursing mothers)
I-Intervention: Oral intake of astaxanthin-containing foods (tablets, capsules, granules, beverages, foods). Compositions containing other ingredients (compositions that also contain ingredients other than astaxanthin as the test substance are excluded.) Combination compositions with other ingredients (compositions that contain ingredients other than astaxanthin as the test substance will be excluded). Astaxanthin intake should be between 0.4 and 30 mg/day.
C-Control: The comparison control will be the consumption of a placebo food that does not contain the relevant functional substances.
O-Outcome: The primary outcome will evaluate the ability to help protect skin moisture. The effect on skin moisture will be evaluated. Specifically, Skin moisture content and Transepidermal water loss are used as endpoints, and both outcomes will be evaluated comprehensively.
S-Study design: Randomized, quasi-randomized, and non-randomized controlled trials (parallel group or crossover controlled trials) will be included.
Key exclusion criteria
Studies which do not meet the key inclusion criteria will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Seki |
Organization
FUJIFILM Corporation
Division name
Consumer Healthcare Business Div.
Zip code
106-8620
Address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo, Japan
TEL
080-1339-9052
shinobu.seki@fujifilm.com
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Oda |
Organization
FUJIFILM Corporation
Division name
Consumer Healthcare Business Div.
Zip code
106-8620
Address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo, Japan
TEL
090-2547-9721
Homepage URL
Yuriko.oda@fujifilm.com
Sponsor or person
Institute
FUJIFILM Corporation
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
Yakujihou Marketing Jimusho Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 07 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research review will be conducted in accordance with PRISMA 2020.
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062887
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/08/05 | 富士フイルム_アスタキサンチン×肌のうるおい_240723_240805修正.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
