UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046976 |
|---|---|
| Receipt number | R000053563 |
| Scientific Title | Exploratory study of skin microstructure analysis including basal sweating by image sensor |
| Date of disclosure of the study information | 2022/02/22 |
| Last modified on | 2024/04/26 09:54:48 |
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Basic information
Public title
Exploratory study of skin microstructure analysis including basal sweating by image sensor
Acronym
Exploratory study of skin microstructure analysis including basal sweating by image sensor
Scientific Title
Exploratory study of skin microstructure analysis including basal sweating by image sensor
Scientific Title:Acronym
Exploratory study of skin microstructure analysis including basal sweating by image sensor
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To examine whether EPIS can image the fine structure of human skin including basal sweating in the same way as IMT. In particular, observe whether the sweat droplets on the skin grooves and hills can be detected accurately, or whether the pattern (texture) of the skin grooves can be detected accurately. (The number of sweat droplets on the skin ridge obtained by IMT, the number of sweat droplets on the skin fold, and the grade classification of the texture. Compare the correlation coefficients of.
2) Since EPIS should be able to detect the amount of water on the surface of the skin, it will be exploratory to investigate whether the secreted sweat can be observed to expand on the surface of the stratum corneum.
Confirm that there are no adverse events on the skin or the subject measured using EPIS.
3) Confirm that there are no adverse events on the skin or the subject measured using EPIS.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of basal sweat droplets secreted to the skin ridge and the skin fold (pieces / cm2) calculated by EPIS is the number of basal sweat droplets secreted to the skin ridge and the skin fold by IMT performed for the same site (pieces / cm2). cm2) match rate
Key secondary outcomes
Correlation coefficient between the number of basal sweat droplets (pieces / cm2) secreted in the skin ridge and fold calculated by EPIS and the water content of the stratum corneum
Match rate between the skin texture grade detected by EPIS and the skin texture grade detected by IMT.
Subjective symptoms (pain score) at the time of examination, skin changes after examination (clinical photograph)
If an adverse event occurs, take out clinical research compensation insurance and deal with it.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Diagnosis
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Person who agree to participate in this trial.
2.Healthy person in research group (OHT employee, research manager, coordinator)
Key exclusion criteria
Person who disagree to participate in this trial.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical School
Division name
Dermatology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
ymaoyama@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | YUMI |
| Middle name | |
| Last name | AOYAMA |
Organization
Kawasaki Medical School
Division name
Dermatology
Zip code
701-0192
Address
577, Matsushima, Kurashiki, Okayama, Japan
TEL
0864621111
Homepage URL
ymaoyama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School Ethics Review Board
Address
577, Matsushima, Kurashiki, Okayama, Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
| 2022 | Year | 02 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2023 3 17 3 cases implemented so far
2024 4 26 1 case implemented so far
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053563
