UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043067 |
|---|---|
| Receipt number | R000049165 |
| Scientific Title | A Study on the Effect of Plant-Derived Products on skin function |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/12/24 15:44:43 |
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Basic information
Public title
A Study on the Effect of Plant-Derived Products on skin function
Acronym
A Study on the Effect of Plant-Derived Products on skin function
Scientific Title
A Study on the Effect of Plant-Derived Products on skin function
Scientific Title:Acronym
A Study on the Effect of Plant-Derived Products on skin function
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of plant-derived products on skin function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture content
Key secondary outcomes
Transepidermal water loss
Skin viscoelasticity
Observation for skin condition by dermatologists
Questionnaire survey (Visual Analogue Scale) on the physical condition
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
Plant-Derived Products, 8 weeks consumption
Interventions/Control_2
Placebo Products, 8 weeks consumption
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
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Females aged 35-49 years.
2)Subjects who are healthy and are not suffered from chronic disease including skin disease.
3)Subjects who are aware of skin dryness.
4)Subjects who can make self-judgment and are voluntarily giving written informed consent.
5)Subjects who can have an examination on a designated check day.
6)Subjects who are judged as suitable for the current study by the investigator.
Key exclusion criteria
Subjects (who)
1)contract disease and are under treatment.
2)with skin disease, such as atopic dermatitis.
3)with strange skin conditions at measurement points.
4)used a drug to treat a disease in the past 1 month.
5)used antibiotics within the last 2 weeks prior to the screening and pre-intake test.
6)have a history of and/or contract serious diseases (eg, liver disease, kidney disease, heart disease, lung disease, blood disease).
7)have a history and/or contract digestive disease.
8)with serious anemia.
9)whose BMI are 30 or more.
10)have allergic reaction to ingredients of test foods and other foods or drugs.
11)have a habit to use drugs claiming to improve skin function in the past 3 months.
12)have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve skin function in the past 3 months and/or are planning to use those foods during test periods.
13)have a habit to take foods related to green juice in the past 3 months and/or are planning to use those foods during test periods.
14)regularly take foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, and/or viable bacteria.
15)are or are possibly pregnant, or are lactating.
16)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent.
17)with psychiatric disease.
18)are smokers.
19)with possible changes of life style during test periods.
20)will develop seasonal allergy symptoms, such as pollinosis, eye and nose symptoms and/or use an anti-allergic drug.
21)neglect skin care.
22)can't avoid direct sunlight exposure, such as sunburn, during test periods.
23)had been conducted an operation or beauty treatment on the test spot in the past 6 months.
24)are participating and/or had participated in other clinical studies within the last 3 months.
25)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
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
| 2021 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049165
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/49100/1689
Number of participants that the trial has enrolled
50
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2021 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Females aged 35 to 49 years old.
Participant flow
Enrolled(n=50)
Completed(n=49)
Analysed(n=39)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Skin moisture content
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049165
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| Registered date | File name |
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