UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010225 |
|---|---|
| Receipt number | R000011965 |
| Scientific Title | Classification of subsets of psoriasis based on expression profile of cytokines in lesional skin of psoriasis |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2015/09/14 19:10:11 |
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Basic information
Public title
Classification of subsets of psoriasis based on expression profile of cytokines in lesional skin of psoriasis
Acronym
Cytokines in lesional skin of psoriasis
Scientific Title
Classification of subsets of psoriasis based on expression profile of cytokines in lesional skin of psoriasis
Scientific Title:Acronym
Cytokines in lesional skin of psoriasis
Region
| Japan |
Condition
Condition
psoriasis
Classification by specialty
| Clinical immunology | Dermatology | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is hypothesized that cytokine profiles in lesional skin of psoriasis could be characteristic to different clinical subsets of psoriasis.
Basic objectives2
Others
Basic objectives -Others
To demonstrate if cytokine profiles have relation to severity of the disease and efficacy of therapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantification TNFa, IL17A, IL12/23p40 mRNA expression in lesional skin of patients with psoriasis at their first visit and the recurrence.
Key secondary outcomes
Ratio of TIP-DC/Th17/Th22 cells and FoxP3+Treg cells in lesional skin of patients with psoriasis at their first visit and the recurrence.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Biopsy of lesional skin of patients with psoriasis is done with local anaesthesia
1. 3mm punch biopsy
2. once at the first visit
3. in case of necessity at the recurrence
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with moderate and severe psoriasis
Key exclusion criteria
1.Patients with severe infection
2.Patients with active tuberculosis
3.Carrier of hepatitis B virus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujimoto Wataru |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Kurashiki-shi, Matsushima 577
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujimoto Wataru |
Organization
Kawasaki Medical School
Division name
Department of Dermatology
Zip code
Address
Kurashiki-shi, Matsushima 577
TEL
086-462-1111
Homepage URL
http://www.kawasaki-m.ac.jp
watarufu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department ofDermatology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
http://www.kawasaki-m.ac.jp
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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 12 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011965
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
