UMIN-CTR Clinical Trial

Basic information
Public title	Examination of foods ingestion containing plant extract 1
Acronym	Examination of foods ingestion containing plant extract 1
Scientific Title	Examination of foods ingestion containing plant extract 1
Scientific Title:Acronym	Examination of foods ingestion containing plant extract 1
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of plant extract on skin and health condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood component
Key secondary outcomes	subjective evaluation

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of placebo food for 4 weeks
Interventions/Control_2	Ingestion of active food for 4 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	25 years-old <=
Age-upper limit	39 years-old >=
Gender	Female
Key inclusion criteria	1. Healthy female aged from 25 to 39 years old 2. Subjects who have dry skin. 3. Subjects who are aware of the inelasticity of the skin 4. Subjects who are aware of skin dullness 5. Subjects who are aware of wrinkles on her skin 6. Menstrual cycle is stable 7. Subjects who can forbid intaking supplements.
Key exclusion criteria	1. Subjects who have been suffered from bronchial asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis 2. Subjects who have the rash resulting from psoriasis or skin allergy 3. Subjects who are outpatients or were treated by doctor recently. 4. Subjects who are using external preparations and/or moisturizer for face and arm 5. Subjects who take medicine 6. Subjects who have received or prohibit a cosmetic medicine (cosmetic surgery, injection of collagen, etc.) in face and arm 7. Subjects who have possibilities for emerging allergy to foods and drugs. 8. Subjects who are pregnant or lactating, or planned to become pregnant in the near future. 9. Current smoker 10. Subjects who are participate in the other clinical studies 11. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Akane Middle name Last name Suma
Organization	Kao Corporation
Division name	Skin Care Products Research
Zip code	131-8501
Address	2-1-3 Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL	81-(0)3-5630-9581
Email	suma.akane@kao.com

Public contact
Name of contact person	1st name Masako Middle name Last name Mizuuchi
Organization	C&C Corporation
Division name	C&C Corporation
Zip code	104-0045
Address	4-7-5, Tukiji, Chuo-ku, Tokyo, 104-0045, JAPAN
TEL	81-(0)3-3545-3781
Homepage URL
Email	m.mizuuchi@candc.co.jp

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Human Reserch Ethics Committee, Kao Corporation
Address	2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel	+81-3-5630-7263
Email	morisaki.naoko@kao.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	築地クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 02 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	Open public recruiting
Date of protocol fixation	2020 Year 09 Month 28 Day
Date of IRB	2020 Year 09 Month 28 Day
Anticipated trial start date	2020 Year 10 Month 02 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047911

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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