Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Psoriasis: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Mean change in Psoriasis Area and Severity Index (PASI) score
研究概览
简要总结
This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in Psoriasis Area and Severity Index (PASI) score from baseline to Week 12. Secondary outcomes include change in body mass index (BMI) and safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups.
详细描述
This pilot study is designed to evaluate the safety and preliminary efficacy of oral roflumilast in adults with moderate-to-severe plaque psoriasis. The study was approved by the Mansoura University Faculty of Medicine Institutional Review Board (IRB), Approval Code: R.25.06.3223.R1, and participants will be enrolled only after obtaining informed consent.
Each participant will undergo a detailed history and clinical examination, including:
Personal history: name, age, sex, occupation, residence, marital status, number of children, and special habits of medical importance.
History of present illness: onset, course, duration of psoriasis, and precipitating factors.
Medication history: nature, route, dose, compliance, duration, effect, and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study: neither the participants nor the investigators are blinded. All participants receive oral roflumilast, and both participants and study staff are aware of the treatment assignment. No placebo or comparator is used.
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
- •Psoriatic patients ≥ 18 years in whom systemic therapy is indicated.
- •Chronic stable plaque psoriasis.
- •Patients who don't use other systemic therapy for psoriasis in the last 2 months (or naïve who didn't use any systemic therapy before).
- •Safe contraception during the study.
排除标准
- •Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- •Age <18 years.
- •Other concomitant psoriasis systemic treatments such as Acitretin and biologics.
- •Previous systemic treatment of psoriasis in the last 2 months.
- •Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
- •Other systemic diseases other than COPD, especially hepatic impairment.
- •Hypersensitivity to the active substance of roflumilast or to any of its excipients
- •The use of contraception with gestodene and ethinylestradiol
- •Unreliable patients.
研究组 & 干预措施
Oral Roflumilast for Adults with Moderate-to-Severe Psoriasis
All participants, both male and female, will receive oral roflumilast.
No placebo or comparator is included.
Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes.
干预措施: Oral roflumilast (Drug)
结局指标
主要结局
Mean change in Psoriasis Area and Severity Index (PASI) score
时间窗: Baseline to Week 12
The mean difference in PASI score from baseline to Week 12 among adults with moderate-to-severe plaque psoriasis receiving oral roflumilast. PASI is a validated composite measure of psoriasis severity assessing erythema, induration, desquamation, and affected body surface area.
次要结局
- Change in body mass index (BMI)(Baseline to Week 12)
研究者
Ahmed Ibrahim
Assistant lecturer of dermatology, Andrology, & STDs , Suez University.
Mansoura University Hospital