UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018550 |
|---|---|
| Receipt number | R000021385 |
| Scientific Title | The clinical study which verifies whether to take Astaxanthine exerts good effect about the state of the skin. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/03/22 16:28:33 |
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Basic information
Public title
The clinical study which verifies whether to take Astaxanthine exerts good effect about the state of the skin.
Acronym
The clinical study which verifies whether to take Astaxanthine exerts good effect about the state of the skin.
Scientific Title
The clinical study which verifies whether to take Astaxanthine exerts good effect about the state of the skin.
Scientific Title:Acronym
The clinical study which verifies whether to take Astaxanthine exerts good effect about the state of the skin.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that capsules containing astaxanthine showed functional effects for skin. In this study, we focusing on the effect in a long-term and dose-dependent manner against the improvement of skin condition. Based on previous studies, maximum dose of astaxanthin used against eyestrain and lipid metabolism disorder was 12mg per day and no report for serious side-effects. To evaluate the effect of consumption of these capsules, we performed 16-week treatment study with healthy adult receiving placebo, astaxanthine 6mg per day and astaxanthine 12mg per day.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The wrincle grade evaluated by a picture of eye area,The wrinkle depth evaluated by replica,The transepidermal water loss
Key secondary outcomes
The stratum corneum water content,The skin elasticity,The ratio of IL-1RA/IL-1alpha of skin corner layer
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 16 weeks
Test material: test food
2 capsules per day (astaxanthin 12mg/day)
Interventions/Control_2
Duration: 16 weeks
Test material: test food
2 capsules per day (astaxanthin 6mg/day)
Interventions/Control_3
Duration: 16 weeks
Test material: Placebo
2 capsules per day (astaxanthin 0mg/day)
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1)Japanese females aged 35-60 years old
2)Individuals who are healthy and do not treat any disease
3)Individuals who possesses wrinkles of the grade 3-5 (a Japanese perfumery academic meeting, guideline) degree in an outer corner of the eye
4)Individuals who worries about roughness
5)Individuals who sign the consent document after explanation of this study
Key exclusion criteria
1)Individuals using medical products
2)Individuals with skin disease, such as atopic dermatitis
3)Individual who gets a tan excessively or Individuals who will get a tan excessively during the test period
4)Individual with fear who causes severe allergy in a food and medical supplies
5)Individual who is pregnant or lactate
6)Individual who have Severe hepatopathy, kidney or heart disease, lung disease, digestive organ disease(including stomach removal), organ obstacle disease, diabetes and thyroid disease, additionally, the individual with whom the past is infected in a severe disease
7)Individual who have a disease of hepatitis
8)Individual with high anemia
9)Individuals with possible changes of life style, such as working a night shift or conducting a long-term travel, during the test period
10)Individuals who are planning to take in the test duration again with the continual absorption custom of medical supplies, an unregulated drug, a preservation of health function food (specified health food), healthy food and supplement that we can think there is a possibility which influences a test result in present and within the for 3 months of past
11)Individuals who participated in other clinical studies in the past three months
12)Individuals who donated blood beyond 400ml in 200ml or within 3 months within the for 1 month of past
13)Individuals judged inappropriate for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yonei |
Organization
Graduate School of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Yamashita |
Organization
Nikoderm Research Inc.
Division name
Department of evaluation
Zip code
Address
1-6-14 Azuchimachi,Chuo-ku,Osaka City, OSAKA
TEL
06-6125-3501
Homepage URL
yamashita@nikoderm.com
Sponsor or person
Institute
Nikoderm Research Inc.
Institute
Department
Personal name
Funding Source
Organization
Fuji Chemical Industries 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
Address
Tel
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
| 2016 | Year | 12 | 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
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
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021385
