The Effectiveness of Lower Cyclosporine Doses for Psoriasis

University of Rochester

Status and phase: Withdrawn; Phase 2

Conditions: Psoriasis

Treatments: Drug: Cyclosporine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00377325

R01AR050100 (U.S. NIH Grant/Contract)

NIH-7R01AR050100

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Participants will receive full dose cyclosporin.

Treatment:

Drug: Cyclosporine

2

Experimental group

Description:

Participants will receive active drug full dose until cleared, then one dose every 4 days.

Treatment:

Drug: Cyclosporine

3

Placebo Comparator group

Description:

Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.

Treatment:

Drug: Cyclosporine