Comparison Study of Psoriasis Severity Assessment Tools
NCT ID: NCT02655705
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2014-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclosporine A
Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks
Cyclosporine A
Male 200 mg/day, Female 150 mg/day for 16 weeks
Methotrexate
Methotrexate was started with 10 mg/week orally as a single dose, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Methotrexate
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Interventions
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Cyclosporine A
Male 200 mg/day, Female 150 mg/day for 16 weeks
Methotrexate
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have \> 5% body surface area involvement at screening
* Are a candidate for systemic therapy
* Are male or female patients 18 years or older
* Have given written informed consent approved by the Institutional Review Board
Exclusion Criteria
* Have had any of the systemic non-biologic psoriasis therapy (including neotigason, cyclosporine, and methotrexate) within 4 weeks prior to baseline
* Have had etanercept within 4 weeks prior to baseline
* Have had adalimumab and infliximab within 8 weeks prior to baseline
* Have had ustekinumab within 16 weeks prior to baseline
* Presence of significant hepatic or renal disorders
* Have uncontrolled arterial hypertension
* Are women who are lactating, breastfeeding or planning pregnancy
* Have any other condition that precludes from following and completing the protocol
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Sang Woong Youn
Associate professor
Principal Investigators
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Sang Woong Youn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Choi JW, Kim BR, Choi CW, Youn SW. One device, one equation: the simplest way to objectively evaluate psoriasis severity. J Dermatol. 2015 Feb;42(2):154-8. doi: 10.1111/1346-8138.12727. Epub 2014 Dec 10.
Choi JW, Kwon SH, Youn JI, Youn SW. Objective measurements of erythema, elasticity and scale could overcome the inter- and intra-observer variations of subjective evaluations for psoriasis severity. Eur J Dermatol. 2013 Apr 1;23(2):224-9. doi: 10.1684/ejd.2013.1931.
Other Identifiers
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oPASI1403
Identifier Type: -
Identifier Source: org_study_id
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