UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study to visualization of the skin lesions by using photoacoustic microscope imaging equipment
Acronym	PMIE Study
Scientific Title	An exploratory study to visualization of the skin lesions by using photoacoustic microscope imaging equipment
Scientific Title:Acronym	PMIE Study
Region	Japan

Condition
Condition	Skin lesions with morphological change located in the epidermis and dermis.
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the capability of visualization of the skin lesions in epidermis and dermis by using a photoacoustic microscope imaging equipment.
Basic objectives2	Others
Basic objectives -Others	To evaluate the capability of visualization of the skin lesions in epidermis and dermis by using a photoacoustic microscope imaging equipment.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The visualization capability of skin lesions in the epidermis and dermis by using a photoacoustic imaging system.
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	Photoacoustic microscope imaging (Duration of the device use is for about two minutes.)
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.Patients who visited our hospital with the skin lesions including pigmented, erythem purpura and vasculitis. 2. The subjects who have agreed to participate in this study from their own free will with document consents.
Key exclusion criteria	1.Patients who are pregnant or suspected of being pregnant 2.People who have skin disorder or complications that make them impossible to try photoacoustic imaging system. 3.People who are judged ineligible to enroll into this clinical study due to limitations in taking examination position by the investigator or the sub-investigators.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Tanikawa
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3823
Email	tanikawa@keio.jp

Public contact
Name of contact person	1st name Kazuyo Middle name Last name Sujino
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Zip code	160-8582
Address	35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3823
Homepage URL
Email	ksujino@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Adventist 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	Keio University School of Medicine Ethics Committee
Address	35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
Tel	03-3353-1211
Email	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	2020 Year 10 Month 01 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	16
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	2020 Year 08 Month 08 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 01 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047898

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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