UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046508 |
|---|---|
| Receipt number | R000053062 |
| Scientific Title | Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2021/12/28 17:34:27 |
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Basic information
Public title
Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Acronym
Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Scientific Title
Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Scientific Title:Acronym
Elucidation of the pathophysiology and establishment of treatment in inflammatory skin diseases
Region
| Japan |
Condition
Condition
inflammatory skin diseases
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of miRNA expression and its function in inflammatory skin diseases
Basic objectives2
Others
Basic objectives -Others
Analysis of miRNA expression and its function in inflammatory skin diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of miRNA in serum and skin samples of patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with inflammatory skin diseases
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Higashi |
Organization
Kagoshima University Hospital
Division name
Dermatology
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima
TEL
099-275-5850
higashiy@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Higashi |
Organization
Kagoshima University Hospital
Division name
Dermatology
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima
TEL
099-275-5850
Homepage URL
higashiy@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Hospital
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6692
crmc@m2.kufm.kagoshima-u.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
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
12
Results
We found that several microRNAs were elevated in inflammatory skin diseases.
Results date posted
| 2021 | Year | 12 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable
Participant flow
Not applicable
Adverse events
Not applicable
Outcome measures
Measurement of miRNA in serum and skin samples of patients
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053062
