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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042501
Receipt No. R000048514
Scientific Title Analyses of the skin molecules in patients with Parkinson's disease and related diseases.
Date of disclosure of the study information 2020/11/19
Last modified on 2020/11/19

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Basic information
Public title Analyses of the skin molecules in patients with Parkinson's disease and related diseases.
Acronym Analyses of the skin molecules in patients with Parkinson's disease and related diseases.
Scientific Title Analyses of the skin molecules in patients with Parkinson's disease and related diseases.
Scientific Title:Acronym Analyses of the skin molecules in patients with Parkinson's disease and related diseases.
Region
Japan

Condition
Condition 1.Healthy adults
2.Parkinson's disease
3.Progressive supranuclear palsy
4.Multiple system atrophy
5.Normal pressure hydrocephalus
Classification by specialty
Neurology Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of differences of skin molecules between healthy adults, Parkinson's disease, and related diseases.
Basic objectives2 Others
Basic objectives -Others The observational study of the relationship between skin molecules and states of Parkinson's disease and related diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences of skin molecules between healthy subjects, subjects with Parkinson's disease, and subjects with related diseases.
Key secondary outcomes The differences of blood components between healthy subjects, subjects with Parkinson's disease, and subjects with related diseases.
The relationship of the molecules between skin and blood.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (The criteria for healthy subjects)
1.Panelists without neurodegenerative diseases.
2.Panelists who agree to have their typical daily routines.
3.Panelists who don't require assistance to participate in this trial.
Panelists who don't require the legally acceptable representatives.

(The criteria for subjects with Parkinson's disease and related diseases)
1.Panelists with Parkinson's disease, progressive supranuclear palsy, multiple system atrophy, or normal pressure hydrocephalus.
2.Panelists who agree to have their typical daily routines.
Key exclusion criteria 1.Panelists who have the type I or II diabetes.
2.Panelists who have the malignant tumors.
3.Panelists who have the skin diseases, such as atopic dermatitis, acne vulgaris, and psoriasis vulgaris.
4.Panelists who have the infectious diseases, such as HIV, HCV, HIV, and syphilis.
5.Panelists who use the antibiotics within 2 weeks before participation in this study.
6.Panelists who use the prescription drugs having any effects to this study.
7.Panelists who use the prescription topical agents on the face
8.Panelists who is considered as inappropriate in this study.

Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takayoshi
Middle name
Last name Inoue
Organization Kao Corporation
Division name Biological Science Research
Zip code 113-8421
Address Juntendo University, Building A, 12F, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL +81-70-3297-0982
Email inoue.takayoshi@kao.com

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Uehara
Organization Kao Corporation
Division name Biological Science Research
Zip code 113-8421
Address Juntendo University, Building A, 12F, 2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL +81-70-3297-1038
Homepage URL
Email uehara.yuuya@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Juntendo University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-9220
Email uesaka.toshio@kao.com

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 順天堂大学医学部付属順天堂医院(東京都)
株式会社インフォワード恵比寿スキンリサーチセンター(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 19 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
2019 Year 02 Month 28 Day
Date of IRB
2019 Year 02 Month 28 Day
Anticipated trial start date
2019 Year 02 Month 28 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The observational study of the relationship between skin molecules and states of Parkinson's disease and related diseases.

Management information
Registered date
2020 Year 11 Month 19 Day
Last modified on
2020 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048514

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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