Evaluation of the nailfold capillaroscopic findings in the patients of psoriasis at baseline and psoriasis area severity index 75 after methotrexate therapy: A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Evaluation of the nailfold capillaroscopic findings in the patients of psoriasis at baseline and psoriasis area severity index 75 after methotrexate therapy
研究概览
简要总结
Patient will be included after taking informed consent.Clinical Examination will be done and determine the extent of Psoriasis Vulgaris, which will be assessed using the Psoriasis Area and Severity Index (PASI) Score.
Nailfold examination : will be done on 4th and 5th fingers of both hands using video dermatoscope and serial photographs will be taken. The parameters including mean capillary loop density, morphology of capillaries, avascular areas and microhaemmorhages will be assessed.
Biochemical Investigation – Endothelial marker {Asymmetric Dimethylarginine (ADMA)} levels will be measured using commercially available ELISA kits.
Methotrexate therapy will be given in dose of 0.4mg/kg/week and maximum upto 25mg/week. Folic acid (5mg/day biweekly except on the day of methotrexate), emollients and antihistaminics will be used as concomitant therapy.
**Follow up assessment:**Clinical evaluation well be done at 2 weekly for 1st 4weeks and then 4weekly upto 16th weeks.Nailfold capillaroscopic examination will be done when the patient will achieve more than 75% reduction in PASI from baseline or at 16weeks, whichever will be earlier.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having moderate to severe plaque psoriasis with psoriais area and severity index more than 10 Patients not taking any systemic treatment since last 1month Patients who are willing to sign the written consent form before participating in the study.
排除标准
- •Patients having connective tissue disorders Patients with diabetes mellitus or peripheral vascular disease or coronary disease or cerebrovascular disease Patients with active visible trauma or cosmetic operations or those with a history of professional finger trauma Pregnant and lactating females Patients with contraindications to methotrexate therapy.
结局指标
主要结局
Evaluation of the nailfold capillaroscopic findings in the patients of psoriasis at baseline and psoriasis area severity index 75 after methotrexate therapy
时间窗: At baseline and at PASI75 OR 16th week whichever is earlier
次要结局
- To correlate nailfold capillaroscopic findings with the biochemical marker of endothelial function(At baseline only)
研究者
Dr Seema Punia
All India Institute of Medical Sciences Bathinda