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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029960
Receipt No. R000034153
Scientific Title Clinical evaluation of Multi-functional Jones matrix OCT on normal skin
Date of disclosure of the study information 2017/11/20
Last modified on 2017/11/14

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Basic information
Public title Clinical evaluation of Multi-functional Jones matrix OCT on normal skin
Acronym Jones matrix OCT evaluation of normal skin
Scientific Title Clinical evaluation of Multi-functional Jones matrix OCT on normal skin
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
Middle name
Last name Yoshiaki Yasuno
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki,Japan
TEL 0298535217
Email yasuno@optlab2.bk.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Yasuno
Organization University of Tsukuba
Division name Faculty of Medicine
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki,Japan
TEL 0298535217
Homepage URL
Email yasuno@optlab2.bk.tsukuba.ac.jp

Sponsor
Institute Faculty of Medicine,University of Tsukuba
Institute
Department

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
Address
Tel
Email

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
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034153

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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