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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010225
Receipt No. 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

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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
Email

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
Email watarufu@med.kawasaki-m.ac.jp

Sponsor
Institute Department ofDermatology, Kawasaki Medical School
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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