UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050681 |
|---|---|
| Receipt number | R000057746 |
| Scientific Title | Observational study of skin thickness and hardness |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/12/13 08:52:11 |
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Basic information
Public title
Observational study of skin thickness and hardness
Acronym
Observational study of skin thickness and hardness
Scientific Title
Observational study of skin thickness and hardness
Scientific Title:Acronym
Observational study of skin thickness and hardness
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the skin thickness and the hardness of each part of body
Basic objectives2
Others
Basic objectives -Others
To evaluate the skin thickness and the hardness in each part of body
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The skin thickness of each part of body
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 20-59
Key exclusion criteria
1. Person who has troubles such as wounds, eczema on a wide range of skin test site (upper arm, forearm, buttocks, thigh, abdomen)
2. Person with contact dermatitis and cutaneous hypersensitivity
3. Person who has infectious diseases or diseases with high bleeding risk
4. Person who is pregnant or may be pregnant
5. Person who plan to get an injection such as vaccine on the test site in 14 days before participating in this study
6. Person regarded as an inappropriate participant.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Mori |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7234
mori.takuya@kao.com
Public contact
Name of contact person
| 1st name | Erina |
| Middle name | |
| Last name | Maeyama |
Organization
Kao Corporation
Division name
Biological Science Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7231
Homepage URL
maeyama.erina@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
+81-3-5630-9064
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 27 | 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
40
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
| 2023 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine the skin condition, comparative analysis among the skin thickness and hardness of each part of body will be implemented on retrospective observational study.
Men and women aged 20-59 will be randomly recruited as subjects.
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057746
