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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031265
Receipt No. 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

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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
Email 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
Email abe@well-b.jp

Sponsor
Institute Wellbe Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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