EUCTR2020-000711-76-DK进行中（未招募）1 期
Efficacy of roflumilast in the treatment of psoriasis – a randomised controlled trial - The PSORRO trial
Alexander Egeberg0 个研究点目标入组 40 人开始时间: 2020年3月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age =18 years
- •Chronic stable plaque psoriasis (min duration 6 months)
- •Body mass index (BMI) > 20 kg/m2
- •Candidate for systemic treatment of psoriasis
- •Negative pregnancy test (only women)
- •Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast) (only applying for fertile women)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- •Current tuberculosis
- •Current viral hepatitis
- •Heart failure (NYHA III-IV)
- •Current or former malignancy (basal cell carcinoma excluded)
- •Current or former depression with suicidal ideation
- •Topical therapy for psoriasis during within 2 of randomization or during study
- •Systemic therapy for psoriasis or psoriatic arthritis within 4 weeks of
- •randomization or during study
- •Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
- •Confirmed pregnancy
- •Planned pregnancy within 6 months
- •Breast feeding
- •Blood donation during study
- •Inability to complete study
研究者
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