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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018550
Receipt No. 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

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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
Email 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
Email yamashita@nikoderm.com

Sponsor
Institute Nikoderm Research Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021385

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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