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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046623
Receipt No. R000053187
Scientific Title An exploratory study to visualization of the skin lesions with alopecia areata and vitiligo vulgaris by using photoacoustic microscope imaging equipment
Date of disclosure of the study information 2022/01/13
Last modified on 2022/01/31

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

Condition
Condition Skin lesions with alopecia areata and vitiligo vulgaris
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We visualize the skin lesions alopecia areata and vitiligo vulgaris by using a photoacoustic microscope imaging equipment.
We obsereve the lesions responsed to treatment and evaluate the equipment performance.
Basic objectives2 Others
Basic objectives -Others -
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To visualize skin lesions with alopecia areata and vitiligo vulgaris by using a photoacoustic imaging system.
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 1.Patients who visited our hospital who have skin lesions with alopecia areata and vitiligo vulgaris on face.

2. Patients over 20 years old (regardless of gender)

3. 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.Patients who have complications that make them
impossible to try photoacoustic imaging system due to limitations in taking examination position.
3.Patients who are judged ineligible to enroll into this clinical study by the investigator or the sub-investigators.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Tanikawa
Middle name
Last name Akiko
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 Sujino
Middle name
Last name Kazuyo
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 Hospital
Institute
Department

Funding Source
Organization Advantest 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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 13 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
2021 Year 11 Month 01 Day
Date of IRB
2021 Year 12 Month 28 Day
Anticipated trial start date
2022 Year 01 Month 13 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information -

Management information
Registered date
2022 Year 01 Month 13 Day
Last modified on
2022 Year 01 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053187

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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