UMIN-CTR Clinical Trial

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