Comparison of Efficacy of Methotrexate Versus Apremilast in the Treatment of Pruritus in Psoriasis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Dermatology Life Quality Index (DLQI) Score
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy of Methotrexate versus Apremilast in reducing pruritus and improving quality of life in patients with psoriasis. Eighty patients aged 20 to 60 years with psoriasis involving more than 8% body surface area and associated pruritus will be enrolled and randomly assigned into two groups. Group A will receive oral Apremilast titrated to 30 mg twice daily, while Group B will receive oral Methotrexate 10 mg once weekly for 8 weeks. The primary outcome will be change in Dermatology Life Quality Index (DLQI) score at 8 weeks. Secondary outcomes include change in numerical rating scale for pruritus and assessment of adverse effects. The study will be conducted at Pakistan Emirates Military Hospital Rawalpindi.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 65 years.
- •Clinically diagnosed cases of psoriasis.
- •Patients experiencing pruritus associated with psoriasis.
- •Patients willing to participate and provide written informed consent.
- •Patients able to comply with study protocol and follow-up visits.
排除标准
- •- Pregnant or lactating women.
- •Patients with severe hepatic or renal impairment.
- •Patients with known hypersensitivity to Methotrexate or Apremilast.
- •Patients currently receiving systemic therapy for psoriasis within the last 4 weeks.
- •Patients with active infections, including tuberculosis.
- •Patients with malignancy.
- •Patients with significant hematological abnormalities.
- •Patients unwilling to provide informed consent.
研究组 & 干预措施
Apremilast Group
Participants will receive oral Apremilast titrated to 30 mg twice daily for 8 weeks.
干预措施: Apremilast (Drug)
Methotrexate Group
Participants will receive oral Methotrexate 10 mg once weekly for 8 weeks.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change in Dermatology Life Quality Index (DLQI) Score
时间窗: 8 weeks
Difference between baseline DLQI score and DLQI score at 8 weeks after treatment.
次要结局
- Change in Pruritus Severity Using Numerical Rating Scale(8 weeks)
研究者
Zarmeen Khawar
FCPS Trainee Dermatology
Pak Emirates Military Hospital