Cyclosporine in the Pharmacotherapy of Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement in psoriasis symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
Participants will receive full dose cyclosporin.
干预措施: Cyclosporine (Drug)
2
Participants will receive active drug full dose until cleared, then one dose every 4 days.
干预措施: Cyclosporine (Drug)
3
Participants will receive active drug full dose until clear, then full dose every 4 days with placebo on the intervening days.
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Improvement in psoriasis symptoms
时间窗: Measured every 2 weeks
次要结局
未报告次要终点
研究者
Francisco Tausk
Professor
University of Rochester