UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038959 |
|---|---|
| Receipt number | R000044430 |
| Scientific Title | A survey of actual skin conditions for humans. |
| Date of disclosure of the study information | 2019/12/23 |
| Last modified on | 2019/12/23 14:04:27 |
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Basic information
Public title
A survey of actual skin conditions for humans.
Acronym
A survey of actual skin conditions for humans.
Scientific Title
A survey of actual skin conditions for humans.
Scientific Title:Acronym
A survey of actual skin conditions for humans.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To pursue the skin changes by aging in healthy Japanese male and female
Basic objectives2
Others
Basic objectives -Others
Observational study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The aging change of individual face characteristics.
Key secondary outcomes
The difference of face characteristics based on sex and age.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy female aged from 20 to 89 years old and healthy male aged from 20 to 49 years old.
2.Person who can agree to participate in the study voluntarily in writing.
3.Person who can agree to be taken several pictures and video including their face.
4.Person who has no trouble in the skin of test sites (face, hands and upper arms).
Key exclusion criteria
1.Person who regularly goes to hospital.
2.Person who has allergy symptoms (i.e. pollen allergy, rhinitis and/or atopic dermatitis) and regularly takes medicine or goes to hospital
3.Person who has allergy to adhesive tape, medical tape and/or rubber.
4.Person who is sensitive to the sun light.
5.Patient with vascular function disorder, or person who has excessive sensitivity to cold.
6.Person who has embedded devices (i.e. Heart pacemaker) in their body.
7.Person with the anamnesis of an alcohol or drug dependence.
8.Person who regularly use medical drug.
9.Person who is pregnant/lactating or who desires to become pregnant.
10.Person who participates in the other clinical studies within 4 weeks in the past.
11.Person who is judged as unsuitable for the study by the investigator for other reasons.
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Amano |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9480
amano.yasuko@kao.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Abe |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-9829
Homepage URL
suzuki.hirokoab@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（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 23 | 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
| 2019 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
To pursue the skin changes by aging in healthy Japanese male and female
Management information
Registered date
| 2019 | Year | 12 | Month | 23 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044430
| 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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