UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036932 |
|---|---|
| Receipt number | R000041994 |
| Scientific Title | Evaluation study of skin character and condition using wearable skin biosensors |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2020/07/25 12:37:12 |
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Basic information
Public title
Evaluation study of skin character and condition using wearable skin biosensors
Acronym
Study of wearable skin biosensors
Scientific Title
Evaluation study of skin character and condition using wearable skin biosensors
Scientific Title:Acronym
Study of wearable skin biosensors
Region
| Japan |
Condition
Condition
Skin disease
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the significance of biological information for skin resistance value that can be evaluated by using wearable biosensors with gold nano-mesh electrode.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the correlation between the skin resistance value using wearable biosensors and the amount of TEWL and stratum corneum hydration with existing measuring instruments.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
to recruit research participants for people over 20 years old.
to Include the participation of those who have skin diseases in the past and present.
Key exclusion criteria
1) Person with serious skin disease at the test area
2) Person with severe heart and muscle disease
3) Person who has metal allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Amagai |
Organization
Keio University School of Medicine
Division name
Dermatology department
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3823
amagai@keio.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Tanese |
Organization
Keio University School of Medicine
Division name
Dermatology department
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3823
Homepage URL
tanese@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dermatology department in Keio University School of Medicine, and Department of Electrical and Electronic Engineering in School of engineering of the university of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Electrical and Electronic Engineering,
School of Engineering, the University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211 (62014)
med-rinri-jimu@adst.keio.ac.jp
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
| 2019 | Year | 06 | Month | 04 | 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 | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective research
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2020 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041994
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
