UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031265 |
|---|---|
| Receipt number | R000035347 |
| Scientific Title | Pre-examination: A confirmatory test for efficacy to skin of the rich nobiletin extract from Shikuwasa. |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2018/06/13 09:49:12 |
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Basic information
Public title
Pre-examination: A confirmatory test for efficacy to skin of the rich nobiletin extract from Shikuwasa.
Acronym
Pre-examination: Evaluation of natural beauty ingredient for skin
Scientific Title
Pre-examination: A confirmatory test for efficacy to skin of the rich nobiletin extract from Shikuwasa.
Scientific Title:Acronym
Pre-examination: Evaluation of natural beauty ingredient for skin
Region
| Japan |
Condition
Condition
Because it is a test for healthy subjects, there is no target disease.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Shikuwasa (scientific name: Citrus depressa) is a plant native to Okinawa since ancient times and contains a lot of "nobiletin" which is one kind of flavonoids. Nobiletin prevents skin damage due to ultraviolet rays, suppresses the formation of melanin pigment, and suppresses skin inflammatioShikuwasa (scientific name: Citrus depressa) is a plant native to Okinawa since ancient times and contains a lot of "nobiletin" which is one kind of flavonoids. Nobiletin prevents skin damage due to ultraviolet rays, suppresses the formation of melanin pigment, and suppresses skin inflammation caused by ultraviolet rays. However, there are few research reports on the efficacy of the Shikuwasa extract to the skin. This study was planned for the purpose of preliminary examination with a small number of examinees in order to confirm the usefulness to the skin using Shikuwasa extract .
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin measurement
1.Stain / wrinkle measurement with Robo SkinAnalyzer
2.Skin viscoelasticity, water content, oil content
Key secondary outcomes
Result of the questionnaire survey
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
| Other |
Interventions/Control_1
Application of lotion containing nobiletin to skin
Interventions/Control_2
Application of a lotion to the skin
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy people who do not have severe disease (diabetes, heart disease, liver disease, kidney disease, cancer, etc.)
2. Women who suffer from skin weakness, spots and wrinkles
3. A person who wishes to voluntarily participate in the clinical trial from the age of 40 to 70 and obtain written consent
4. Those who have not changed the basic cosmetics or cosmetics within the first month before the start of the test and those who can not change during the test period
5. The use of basic cosmetics during the examination period can be used only for the test item
6. Persons who do not constantly consume health food or the like considered to have an effect on the skin within one month before commencement of testing
7. Those who have not received any special skin care treatment during the examination from 1 month before the examination
8. Those who can avoid drastic changes in UV exposure such as swimming, mountain climbing, sunbathing, outdoor exercise compared to before the test
9. Persons who can keep constant daily lifestyle during the examination period
10. Study participation of people who are treating mild chronic diseases (hypertension, hyperlipemia, etc.) shall be able to participate at the discretion of the investigator
Key exclusion criteria
1. People with severe diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) and mental disorders
2. One who ingests internal or external medicine for atopic dermatitis, skin diseases such as urticaria, etc, regularly or within 1 month taking 1/3 of the month or more
3. People with skin conditions and skin diseases that may have an impact on the test
4. Cosmetics containing seekers, those who have experienced allergic symptoms in food, people with drug allergy
5. Pregnant women / lactating women and those who wish pregnancy during the examination period
6. Other persons who did not qualify for participation in the exam by the investigator
7. If you are participating in other clinical trials within the past month
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishiyama, Masaki |
Organization
Wellbe Inc.
Division name
Clinical Research Division
Zip code
Address
Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
TEL
098-988-9007
abe@well-b.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Abe, Hiroyuki |
Organization
Wellbe Inc.
Division name
Clinical Research Division
Zip code
Address
Tanahara BLDG 3F, 1-3-2 Nishihara, Urasoe, Okinawa, Japan
TEL
098-988-9007
Homepage URL
abe@well-b.jp
Sponsor or person
Institute
Wellbe Inc.
Institute
Department
Personal name
Funding Source
Organization
Okinawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 15 | 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
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035347
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