UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study to evaluate the effects of the Linablue tablet on skin function
Acronym	A clinical study to evaluate the effects of the Linablue tablet on skin function
Scientific Title	A clinical study to evaluate the effects of the Linablue tablet on skin function
Scientific Title:Acronym	A clinical study to evaluate the effects of the Linablue tablet on skin function
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of the Linablue tablet on skin function in a randomized, double-blind, placebo-controlled, parallel-group comparative study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Transepidermal Water Loss (TEWL)
Key secondary outcomes	Hydration level of the skin surface Elasticity of the upper skin layer Skin replica analysis (wrinkles and texture) Microscopic analysis by the dermatologist (wrinkles and spots)

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	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of the test food (tablets that contain Linablue ) for 8 weeks
Interventions/Control_2	Intake of the placebo (tablets that don't contain Linablue) 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Female
Key inclusion criteria	1)Healthy females whose age of 20 years or more and less than 65 years 2)Subjects who experience dry skin 3)Subjects having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria	1)Subjects who are dermatological patients 2)Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 3)Subjects having the possibility of developing allergic symptoms by the test food 4)Subjects taking regularly foods for specified health uses, foods with function claims labeled, medicines or quasi-drugs having the effects on skin function 5)Subjects who are pregnant or lactating, or intending to become pregnant during the study 6)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in another clinical study 7)Subjects deemed unsuitable by the investigator
Target sample size	96

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Imai
Organization	DIC Corporation
Division name	Application Materials Technology & Production Group
Zip code	290-8585
Address	12, Yawatakaigandori, Ichihara, Chiba
TEL	0436-41-4128
Email	yasuyuki-imai@ma.dic.co.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Sugino
Organization	Soiken Inc.
Division name	R&D Division
Zip code	560-0082
Address	Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	None
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	IRB of Fukuda Clinic
Address	Shin-OsakaBrick Building 2F, 1-6-1, Miyahara,Yodogawa-ku, Osaka, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.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 03 Month 31 Day

Related information
URL releasing protocol	https://mol.medicalonline.jp/archive/search?jo=ai6yrtyb&ye=2019&vo=47&issue=11
Publication of results	Published

Result
URL related to results and publications	https://mol.medicalonline.jp/archive/search?jo=ai6yrtyb&ye=2019&vo=47&issue=11
Number of participants that the trial has enrolled	96
Results	https://mol.medicalonline.jp/archive/search?jo=ai6yrtyb&ye=2019&vo=47&issue=11
Results date posted	2021 Year 12 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Test food group female n=48 age: mean 45.1, SD 8.3 years Placebo group female n=48 age: mean 45.2, SD 10.9 years
Participant flow	Screening examination n=96 Enrollment n=96 Randomization n=96 Analysis n=93
Adverse events	In the intake period, 8 and 11 adverse events were individually noted in the test food group and placebo group, respectively, and adverse events were not severe or related to the administration of the test food.
Outcome measures	Transepidermal Water Loss(TEWL) Hydration level of the skin surface Elasticity of the upper skin layer Skin replica analysis (wrinkles and texture) Microscopic analysis by the dermatologist (wrinkles and spots)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 11 Month 17 Day
Date of IRB	2018 Year 11 Month 17 Day
Anticipated trial start date	2018 Year 12 Month 15 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 10 Day
Last modified on	2021 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040088