The Effectiveness of Lower Cyclosporine Doses for Psoriasis
NCT ID: NCT00377325
Last Updated: 2014-11-21
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2007-06-30
2013-09-30
Brief Summary
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Detailed Description
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Participants in this study will receive treatment with cyclosporine for up to 30 weeks. Study visits will occur every 2 weeks and will include a physical exam, a psoriasis symptom evaluation, blood collection, and various questionnaires on quality-of-life issues. Participants will be followed for 2 years.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants will receive full dose cyclosporin.
Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
2
Participants will receive active drug full dose until cleared, then one dose every 4 days.
Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
3
Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.
Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
Interventions
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Cyclosporine
4 mg/Kg/day; daily; liquid form; 6 months
Eligibility Criteria
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Inclusion Criteria
* Exception that has been resistant to psoralen and ultraviolet A radiation (PUVA), methotrexate, and retinoids
* Moderate to severe, stable plaque psoriasis
* Normal organ and marrow function
* HIV uninfected
Exclusion Criteria
* Use of systemic, intralesional, or phototherapy within 1 year of study entry
* Use of cyclosporine in the past or use of other immunosuppressive medication within 6 months of study entry
* Inability to be followed or monitored regularly on a weekly basis
* Poorly controlled hypertension
* Severe infection, internal malignancy, immunodeficiency, gout, or liver disease
* Received more than 1,000 treatments of ultraviolet A (UVA)
* History of allergic reaction attributed to compounds of similar chemical or biological composition to cyclosporine
* Uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia that would limit study participation
* Women of childbearing potential and men unwilling to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of the study
* Pregnant
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Rochester
OTHER
Responsible Party
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Francisco Tausk
Professor
Principal Investigators
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Francisco Tausk, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Department of Dermatology
Rochester, New York, United States
Countries
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Other Identifiers
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