UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032330 |
|---|---|
| Receipt number | R000036869 |
| Scientific Title | Analysis of immunological abnormalitiy in inflammatory skin diseases |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/04/23 11:06:59 |
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Basic information
Public title
Analysis of immunological abnormalitiy in inflammatory skin diseases
Acronym
Analysis of immunological abnormalitiy in inflammatory skin diseases
Scientific Title
Analysis of immunological abnormalitiy in inflammatory skin diseases
Scientific Title:Acronym
Analysis of immunological abnormalitiy in inflammatory skin diseases
Region
| Japan |
Condition
Condition
atopic dermatitis, psoriasis, Behcet's disease
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immunological abnormality of inflammatory cells in inflammatory skin diseases
Basic objectives2
Others
Basic objectives -Others
To investigate the mechanism of protein regulation in inflammatory cells in inflammatory skin diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the abnormality of cytokine production and signal transduction pathways induced by inflammatory cells
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To take blood samples from patients
Interventions/Control_2
To take blood samples from healthy controls
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with atopic dermatitis, psoriasis, Behcet disease, and other inflammatory skin diseases. healthy controls (over 18 year old, under 70 year old).
Key exclusion criteria
persons which is not involed in the category above.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Medical University
Division name
Department of Dermatology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi,Irumagun, Saitama
TEL
049-276-1247
nakamu@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Nakamura |
Organization
Saitama Medical University
Division name
Department of Dermatology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi,Irumagun, Saitama
TEL
049-276-1247
Homepage URL
nakamu@saitama-med.ac.jp
Sponsor or person
Institute
Department of Dermatology, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
General Research Field of Dermatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Meddical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun
Tel
0492762143
nakamu@saitama-med.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
| 2018 | Year | 05 | Month | 01 | 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
28
Results
Peripheral blood were collected and dendritic cells were generated . Cytokine production was measured.
Results date posted
| 2021 | Year | 04 | Month | 23 | Day |
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
| 2014 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036869
