UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042625 |
|---|---|
| Receipt number | R000048642 |
| Scientific Title | A Survey of Sensitive Skin Consciousness and Inflammatory Conditions |
| Date of disclosure of the study information | 2020/12/02 |
| Last modified on | 2020/12/02 14:37:20 |
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Basic information
Public title
A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Acronym
A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Scientific Title
A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Scientific Title:Acronym
A Survey of Sensitive Skin Consciousness and Inflammatory Conditions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the association with sensitive skin consciousness and inflammatory conditions.
Basic objectives2
Others
Basic objectives -Others
Survey on actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
association with sensitive skin consciousness and inflammatory conditions
Key secondary outcomes
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
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy females
Key exclusion criteria
-Subjects have abnormalities on the skin of the test site (face, inside forearm)
-Subjects attend medical institutions at all times
-Subjects use medicines on a 2-day- and 7-day-long
-Subjects have received cosmetic medicine
-Subjects judged by the person in charge of the examination to be inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Tojo |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-9557
tojo.kaori@kao.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Haketa |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-7286
Homepage URL
haketa.noriko@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, Japan 1318501
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
デルマラボ株式会社（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Verify the association with sensitive skin consciousness and inflammatory conditions.
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048642
| 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 |
