Clinical trial NCT00377325: The Effectiveness of Lower Cyclosporine Doses for Psoriasis
Official title: Cyclosporine in the Pharmacotherapy of Psoriasis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2006-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 treating individuals with moderate to severe psoriasis.

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 inflamed skin, which can itch, crack, and bleed. Cyclosporine is an immunosuppressant drug that is used in more severe cases of psoriasis to slow down the growth of skin cells. However, cyclosporine use is associated with several side effects, including kidney damage, high blood pressure, and skin sensitivity. 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 the standard administration of cyclosporine.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Improvement in psoriasis symptoms
timeFrame: Measured every 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Dermatology
state: New York
Study officials:
affiliation: University of Rochester
name: Francisco Tausk, MD
role: PRINCIPAL_INVESTIGATOR
References: