Efficacy and safety of methotrexate alone and as add on to topical calcipotriol in plaque psoriasis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate and compare the effectiveness and safety of methotrexate alone versus methotrexate with topical calcipotriol
研究概览
简要总结
Psoriasis is a common, chronic, proliferative skin disorder usually characterized by sharply demarcated, scaly, indurated plaques, mostly affecting extensor surfaces and scalp. Plaque psoriasis is the most common (approximately 90%) form. Treatment is essentially lifelong and a large proportion of patients require medication changes and regular follow-up. We conducted an observational study comparing two regimens currently being used in our tertiary care hospital for the treatment of resistant plaque psoriasis.
Adult patients of plaque psoriasis, of either sex, receiving methotrexate only versus methotrexate along with topical calcipotriol, were enrolled between February 2016 to June 2017. Observation was carried out prospectively over 16 weeks to assess effectiveness in terms of Psoriasis Area & Severity Index (PASI) score, safety and changes in quality of life (QoL).
Fifty patients consented to participate, of whom data of 25 on oral methotrexate (dose 5 - 10 mg weekly) alone and 22 on oral methotrexate plus topical calcipotriol 0.005% once/twice daily, were available for analysis. Study participants were mostly middle aged males. The combination group achieved a reduction of 72.75% from baseline in PASI score while methotrexate alone group achieved 54.94% reduction (p < 0.05 on intergroup comparison). No significant adverse reactions were observed over 16 weeks and QoL improvements in the two groups were comparable.
Therefore, in conclusion, combination of methotrexate and topical calcipotriol can be a more effective alternative to methotrexate alone in chronic plaque psoriasis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Age more than 18 years of either gender 2.Treatment naive patients of plaque psoriasis 3.Patients of plaque psoriasis receiving methotrexate.
排除标准
- •1.Pregnant and lactating women 2.Patients immunocompromised due to drug or disease/impaired liver/renal/hematological functions.
结局指标
主要结局
To evaluate and compare the effectiveness and safety of methotrexate alone versus methotrexate with topical calcipotriol
时间窗: Baseline,4 weeks,8 weeks,16 weeks
次要结局
- To assess and compare the quality of life in plaque psoriasis patients(Baseline and 16 weeks)
