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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034574
Receipt No. R000039415
Scientific Title The study to evaluate variations of skin molecules in the day and from day to day.
Date of disclosure of the study information 2018/10/19
Last modified on 2018/11/21

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Basic information
Public title The study to evaluate variations of skin molecules in the day and from day to day.
Acronym The study to evaluate variations of skin molecules in the day and from day to day.
Scientific Title The study to evaluate variations of skin molecules in the day and from day to day.
Scientific Title:Acronym The study to evaluate variations of skin molecules in the day and from day to day.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the variations of skin molecules in the day and from day to day.
Basic objectives2 Others
Basic objectives -Others To evaluate the regional differences of skin molecules between face and scalp.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The variations of skin molecules in the day and from day to day.
Key secondary outcomes -The relationship between skin molecules and questionnaires.
-The evaluation of regional differences of skin molecules between face and scalp.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria 1.Healthy male panelists who are 20-49 years old.
2.Healthy female panelists who are 20-49 years old and have regular menstruation.
3.Panelists who agree to have their typical daily routines.
Key exclusion criteria 1.Panelists who have irregular menstruation or who experience menopause.
2.Panelists who has become pregnant and breast-feeding. In addition, panelists who have possibility of pregnant during the study period.
3.Panelists who have the skin problems on the face, such as atopic dermatitis, psoriasis vulgaris, and acnes.
4.Panelists who have a severe tanning on the face.
5.Panelists who smoke.
6.Panelists who use the drug such as, anti-inflammatory drug, antibiotics, hypnotic, anti- allergic drug, analgesic drug, hormone preparation, laxative, intestinal regulator, and other drugs as routinely.
7.Panelists who attend for treatment of chronic diseases (e.g. stomach, intestine, kidney, heart, blood pressure, skin, and other illness) or have history of attending within a month before participation in this study (Manual therapy, chiropractic, massages, and osteopathic manipulation are exceptional).
8.Panelists who attend cosmetic therapy (e.g. chemical peeling, laser therapy) or have history of cosmetic surgery (e.g. cosmetic orthopedics, collagen injection).
9.Male panelists who randomly shave during the study period. Female panelists who randomly remove downy hairs on their face during the study period.
10.Panelists who have participated or scheduled in other study during the study period.
11.Panelists who is considered as inappropriate in this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayoshi Inoue
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 070-3297-0982
Email inoue.takayoshi@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Yui Ueda
Organization Kao Corporation
Division name Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 070-3297-0962
Homepage URL
Email ueda.yui@kao.com

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
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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 19 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 10 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the regional differences of skin molecules between face and scalp.

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039415

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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