UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034574 |
|---|---|
| Receipt number | 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 | 2020/10/21 08:34:25 |
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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 | Takayoshi |
| Middle name | |
| Last name | Inoue |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
070-3297-0982
inoue.takayoshi@kao.com
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Ueda |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
070-3297-0962
Homepage URL
ueda.yui@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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 Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@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
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039415
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
