UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039207 |
|---|---|
| Receipt number | 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 08:57:26 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044711
