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

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 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


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

Value
https://center6.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