Status:
WITHDRAWN
The Effectiveness of Lower Cyclosporine Doses for Psoriasis
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will evaluate whether lower doses of cyclosporine can cause fewer side effects and still produce the same beneficial results that are seen with a standard cyclosporine dose regimen when tre...
Detailed Description
Psoriasis is a chronic inflammatory skin disease. It is believed to be caused by an overactive immune system that speeds the growth of skin cells. This abnormal skin growth results in patches of infla...
Eligibility Criteria
Inclusion
- Good health
- 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
- Topical therapy within 4 weeks of study entry
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00377325
Start Date
June 1 2007
End Date
September 1 2013
Last Update
November 21 2014
Active Locations (1)
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1
University of Rochester Department of Dermatology
Rochester, New York, United States, 14642