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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039207
Receipt No. R000044711
Scientific Title Evaluation study of intake of elastin supplements derived from bonito on improvement of skin conditions
Date of disclosure of the study information 2020/01/20
Last modified on 2020/07/17

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Basic information
Public title Evaluation study of intake of elastin supplements derived from bonito on improvement of skin conditions
Acronym Evaluation study of intake of elastin supplements derived from bonito on improvement of skin conditions
Scientific Title Evaluation study of intake of elastin supplements derived from bonito on improvement of skin conditions
Scientific Title:Acronym Evaluation study of intake of elastin supplements derived from bonito on improvement of skin conditions
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intake of elastin supplements derived from bonito in improving skin conditions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes transepidermal water loss before intake, 4,8 weeks after intake and 4 weeks after the end of intake
Key secondary outcomes

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 Daily intake of test food for 8 weeks
Interventions/Control_2 Daily intake of placebo food for 8 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
30 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy Japanese males and females aged 30 to 50 years old
2) Subjects who feel sagging skin
3) Subjects who feel dry skin
4) Subjects who feel rough skin
5) Subjects who feel rough skin or itchy skin on either of right cheek, right neck, upper back, right shin or right back leg due to dry air from October to March every year
6) Subjects who feel cold hands or head
7) Subjects who do have stable life style such as eating or sleeping habits
Key exclusion criteria 1) Subjects who have chronic inflammation of the skin such as atopic dermatitis
2) Subjects who took cosmetics containing hyaluronic acid, collagen, ceramide or vitamins in the last 1 month
3) Subjects who took supplements containing hyaluronic acid, collagen, ceramide or vitamins in the last 1 month
4) Subjects who currently go to the dermatology
5) Subjects who participate/participated in other clinical trials intaking food, medicine or cosmetics in the last 3 months
6) Subjects who are pregnant, lactating or possibly pregnant
7) Subjects who participate in other clinical trials
8) Subjects who can be allergic to the test food
9) Subjects who can be allergic to ingredients of the test food
10) Subjects who have remarkable abnormality on skin condition of the test area
11) Subjects who have chronic disease and use medicine daily
12) Subjects who engage in shift work
Target sample size 56

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code 105-0013
Address DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name Ko
Middle name FUJITA
Last name Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code 105-0013
Address DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization Hayashikane Sangyo Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiba Palace Clinic Ethics Review Committee
Address DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel 03-5408-1599
Email shiba_palace@s-palace-clinic.com

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
2020 Year 01 Month 20 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 56
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
2019 Year 10 Month 21 Day
Date of IRB
2019 Year 10 Month 31 Day
Anticipated trial start date
2019 Year 11 Month 08 Day
Last follow-up date
2020 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 20 Day
Last modified on
2020 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044711

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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