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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041975
Receipt No. R000047911
Scientific Title Examination of foods ingestion containing plant extract 1
Date of disclosure of the study information 2020/10/02
Last modified on 2020/10/02

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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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