UMIN-CTR Clinical Trial

Basic information
Public title	Analyses of the skin molecules in patients with Parkinson's disease(2)
Acronym	Analyses of the skin molecules in patients with Parkinson's disease(2)
Scientific Title	Analyses of the skin molecules in patients with Parkinson's disease(2)
Scientific Title:Acronym	Analyses of the skin molecules in patients with Parkinson's disease(2)
Region	Japan

Condition
Condition	1.Healthy adults 2.Parkinson's disease
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 and Parkinson's disease.
Basic objectives2	Others
Basic objectives -Others	The observational study of the relationship between skin molecules and states of Parkinson's disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The differences of skin molecules between healthy subjects and subjects with Parkinson's disease.
Key secondary outcomes	The differences of blood components between healthy subjects and subjects with Parkinson's disease. 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	40 years-old <=
Age-upper limit	89 years-old >=
Gender	Male
Key inclusion criteria	[The criteria for healthy subjects] 1.Healthy panelists who are 40-89 years old without Parkinson's disease. 2.Panelists who agree to have their typical daily routines. 3.Panelists who don't require assistance to participate in this trial. 4.Panelists who don't require the legally acceptable representatives. [The criteria for subjects with Parkinson's disease] 1.Panelists with sporadic Parkinson's disease (Hoehn & Yahr stage I or II). 2.Japanese male panelists who are 40-89 years old. 3.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	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takayoshi Inoue
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7498
Email	inoue.takayoshi@kao.com

Public contact
Name of contact person	1st name Middle name Last name Yuya Uehara
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7461
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
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	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	2019 Year 03 Month 08 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	Completed
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 03 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 11 Month 19 Day

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

Management information
Registered date	2019 Year 03 Month 07 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=R000041140