UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036115 |
|---|---|
| Receipt number | R000041140 |
| Scientific Title | Analyses of the skin molecules in patients with Parkinson's disease(2) |
| Date of disclosure of the study information | 2019/03/08 |
| Last modified on | 2020/11/19 15:22:29 |
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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
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
uehara.yuuya@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041140
