Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
研究概览
简要总结
The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.
详细描述
The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body
- •Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria
- •Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location
排除标准
- •Inability to understand consent or comply with study requirements
- •Pregnancy or unwillingness to use adequate birth control method
- •Lactation
- •Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months)
- •Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks
- •Active tuberculosis or other opportunistic infection
- •Demyelinating disease
- •Uncontrolled congestive heart failure
- •Known allergy to or any contraindications to using topical tacrolimus or etanercept
- •Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR
研究组 & 干预措施
未命名试验
干预措施: Etanercept plus tacrolimus (Drug)
结局指标
主要结局
The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
Target lesion scoring (on a scale of 0-12) at week 12
次要结局
- Photography of target lesions
- Quarter-body photography
- Static Physician's Global Assessment (PGA) on each side of each subject's body