UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035205 |
|---|---|
| Receipt number | R000040088 |
| Scientific Title | A clinical study to evaluate the effects of the Linablue tablet on skin function |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/12/15 11:44:46 |
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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
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040088
