UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038110 |
|---|---|
| Receipt number | R000043440 |
| Scientific Title | Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/03/31 13:06:53 |
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Basic information
Public title
Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Acronym
Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Scientific Title
Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Scientific Title:Acronym
Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the profiles of sebum-derived and stratum corneum-derived component
Basic objectives2
Others
Basic objectives -Others
To compare the profiles of sebum-derived and stratum corneum-derived component
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the profiles of sebum-derived and stratum corneum-derived component
Key secondary outcomes
Comparison of the yield and analysis accuracy of sebum-derived and stratum corneum-derived component
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy male and females who are 20-59 years old.
2) Subjects who can provide informed consent.
Key exclusion criteria
1) Subjects who have the skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis vulgaris.
2) Subjects who have excessive sunburn on face.
3) Subjects who regularly use over-the-counter or prescription drugs.
4) Subjects who regularly visit hospital or who visit hospital due to diseases within a month.
5) Subjects who recently receive beauty treatment or who have received beauty medical care thus far.
6) Subjects who are in irregular menstruation or who passed over the menopause.
7) Subjects who are in pregnancy or lactating period, or who have a possibility of pregnant during the study period.
8) Subjects who use prescription topical agents on face
9) Subjects who use the prescription drugs having any effects to this study.
10) Subjects who are deemed inappropriate to participate in this study by the principle investigator.
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
+81-285-68-5785
inoue.takayoshi@kao.com
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Yano |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan
TEL
+81-285-68-7888
Homepage URL
yano.michiko@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
+81-3-5630-7263
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparative analysis of the profiles of sebum-derived and stratum corneum-derived component
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043440
