EFFICACY OF ROFLUMILAST IN THE TREATMENT OF FLEXURAL AND/OR GENITAL PSORIASIS: A RANDOMIZED CONTROLLED TRIAL.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis
研究概览
简要总结
Psoriasis affecting sensitive anatomical regions, such as the skin folds (flexural or inverse psoriasis) and genitalia, presents unique therapeutic challenges. These manifestations often result in a disproportionately high burden of disease, causing significant physical discomfort and a profound negative impact on a patient's quality of life and sexual health. While topical creams are the standard first-line treatment, many patients have "topically resistant" disease that requires a systemic (oral) approach.
This 16-week randomized controlled trial is the first to directly compare two oral medications for these specific sites: roflumilast (a daily 500 mcg pill) and methotrexate (a standard weekly dose). The study's primary objective is to evaluate which treatment is more effective at clearing psoriatic lesions in the skin folds and genital area, and how each drug improves the patient's overall quality of life and symptoms like pruritus (itching).
Participants are randomly assigned to one of the two treatment groups and are monitored monthly to assess skin clearance, symptom relief, and safety/tolerability. The goal of this research is to provide patients and healthcare providers with evidence-based data on a convenient, oral treatment option that does not require intensive laboratory monitoring.
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
- None
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 ≥ 18 years old.
- •Patients of both genders.
- •Patients with flexural and/or genital psoriasis that has been resistant to topical treatment, "No clearance or near clearance of lesions despite being compliant to treatment for 4 to 6 weeks".
排除标准
- •Major systemic illness (cardiac, respiratory, renal, hepatic and gastrointestinal system).
- •Severe anemia, leucopenia or thrombocytopenia.
- •Pregnant and breastfeeding females.
- •Hypersensitivity /intolerance to Roflumilast or methotrexate.
- •Intake of systemic therapy for psoriasis within the last 3 Months.
- •Patients receiving any relevant topical treatment for at least 2 weeks before initiation of our study.
- •Erythrodermic, pustular psoriasis or psoriatic arthritis.
- •Patients with autoimmune diseases e.g., SLE.
- •Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.
- •Patients on biological therapy within the last 6 months prior to recruitment.
研究组 & 干预措施
Oral Roflumilast 500 mcg daily
This arm receives oral roflumilast at a fixed dose of 500 mcg once per day for 16 weeks. Since systemic roflumilast is currently used off-label for psoriasis and is the novel intervention being investigated in this study, it is classified as the experimental arm.
干预措施: Roflumilast 500 Mcg Oral Tablet (Drug)
Weekly Methotrexate (0.2-0.4 mg/kg)
This arm receives methotrexate at a dose of 0.2-0.4 mg/kg once weekly for 16 weeks. As methotrexate is a well-established standard systemic therapy for psoriasis, it serves as the active control to which the experimental drug is being compared
干预措施: Methotrexate (Drug)
结局指标
主要结局
Clinical Success at flexural (I-IGA 0/1) and/or genital (sPGA-G 0/1) psoriasis
时间窗: week 16
The proportion of patients achieving a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at the specific sensitive sites. This is assessed using the Investigator's Global Assessment for Flexural Psoriasis (I-IGA) for skin folds and the static Physician's Global Assessment of Genitalia (sPGA-G) for genital involvement.
次要结局
- Global Skin Clearance (PASI Responses)(Week 16)
- Quality of Life Improvement (DLQI 0/1)(week 16)
- Itch Relief (Itch-NRS)(week 16)
- Safety and Tolerability (Adverse Events)(Throughout the 16-week treatment period and during the follow-up period (at least 3 months))
- Body Surface Area (BSA) Reduction(week 16)
研究者
Eman Raafat Said
Associate professor
Cairo University