EUCTR2021-006931-25-DK进行中（未招募）1 期
Efficacy and safety of oral roflumilast in the treatment of palmoplantar pustulosis – a randomised controlled trial
Bispebjerg and Frederiksberg Hospital, University of Copenhagen0 个研究点目标入组 28 人开始时间: 2022年1月4日最近更新:
适应症
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
- 28
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
- •PPP diagnosis for min. 3 months
- •PPPASI = 10
- •Active pustules, n = 10
- •Body mass index (BMI) = 20 kg/m2
- •Eligibility for systemic PPP treatment
- •Negative pregnancy test (women)
- •Safe anticonception during entire study and at least 1 week after end of treatment (~5 times plasma half-life of roflumilast)
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Plaque psoriasis with body surface area (BSA) = 20%
- •Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- •Current tuberculosis
- •Current viral hepatitis
- •Heart failure (NYHA III-IV)
- •Moderate or severe liver failure (Child-Pugh B-C)
- •Current or former depression with suicidal ideation
- •Topical medical PPP therapy 2 weeks before randomization and during study
- •Systemic PPP therapy 4 weeks before randomization and during study
- •Treatment with theophylline, phenobarbital, carbamazepine, or phenytoin
- •Previous treatment with apremilast (Otezla®)
- •Confirmed pregnancy
- •Planned pregnancy within 6 months
- •Breast feeding
- •Blood donation during study
- •Inability to complete study
研究者
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