UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pre-examination: A confirmatory test for efficacy to skin of the rich nobiletin extract from Shikuwasa.
Title of the study (Brief title)	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	Nishiyama, Masaki
Organization	Wellbe Inc.
Division name	Clinical Research Division
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	Abe, Hiroyuki
Organization	Wellbe Inc.
Division name	Clinical Research Division
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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