UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029960 |
|---|---|
| Receipt number | R000034153 |
| Scientific Title | Confirmation of the principle of Multi-functional Jones matrix OCT for skin imaging |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2020/11/20 09:37:05 |
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Basic information
Public title
Confirmation of the principle of Multi-functional Jones matrix OCT for skin imaging
Acronym
Jones matrix OCT evaluation of normal skin
Scientific Title
Confirmation of the principle of Multi-functional Jones matrix OCT for skin imaging
Scientific Title:Acronym
Jones matrix OCT evaluation of normal skin
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of information obtained by human skin imaging by Jones matrix OCT in dermatology and cosmetic science.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative observation of image data obtained by a custom-made imaging device (JM-OCT), and quantitative feature values obtained by the image.
Key secondary outcomes
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
Weak near-infra red light illumination to the subject's skin. The light power is confined by the ANSI safety standard.
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
1.Normal subjects without marked skin disorder.
2.After receiving sufficient explanation for the participation of this study, those who gained written consent by the with sufficient understanding
Key exclusion criteria
1.Subjects with difficulty in confirming their agreement on participation.
2.Subjects with marked skin disorders.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Yasuno |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
Tennodai 1-1-1, Tsukuba, Ibaraki,Japan
TEL
0298535217
yasuno@optlab2.bk.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Yasuno |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
Tennodai 1-1-1, Tsukuba, Ibaraki,Japan
TEL
0298535217
Homepage URL
yasuno@optlab2.bk.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Medicine,University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kao
Name of secondary funder(s)
Kao
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
University of Tsukuba Hospital Amakubo 2-1-1, Tsukuba, Ibaraki,Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
| 2017 | Year | 11 | Month | 20 | 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
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034153
| 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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