Roflumilast Versus Methotrexate in the Treatment of Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis Severity Index (PASI) before and after Roflumilast
研究概览
简要总结
Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis
详细描述
Phosphodiesterase (PDE-4) activity was found to be greater in psoriatic skin than in healthy skin. Inhibition of PDE-4 inhibits the hydrolysis of cyclic AMP in inflammatory cells, which increases intracellular cAMP and results in down-regulation of immune modulators, including tumor necrosis factor (TNF)- α, interferon-γ, interleukin (IL)-17, and IL-23. Roflumilast is a potent and selective inhibitor of PDE-4 which is already approved in its oral form for chronic obstructive pulmonary disease. Regarding Roflumilast's topical form, it is currently also approved in the treatment of psoriasis. Lebwohl et al., 2020 found that roflumilast cream was efficacious in reducing the severity of psoriasis in a 12-week, randomized, double-blind, placebo vehicle-controlled trial.
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 (Participant, Outcomes Assessor)
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
- •Patients with psoriasis vulgaris
- •Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
- •Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study
排除标准
- •Erythrodermic or pustular psoriasis
- •Pregnant and lactating females
- •Patients with autoimmune diseases e.g. systemic lupus erythematosus
- •Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
研究组 & 干预措施
Roflumilast
oral roflumilast in a dose of 500 mcg per day
干预措施: Roflumilast (Drug)
Methotrexate
oral methotrexate in a dose of 0.2- 0.4 mg/kg/week
干预措施: Methotrexate (Drug)
结局指标
主要结局
Psoriasis Severity Index (PASI) before and after Roflumilast
时间窗: 12 weeks
Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72.
Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate
时间窗: 12 weeks
Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72.
次要结局
未报告次要终点
研究者
Dina Saadi
Associate Professor of Dermatology
Cairo University