Comparison of efficacy and safety of oral Methotrexate versus oral Tofacitinib in palmoplantar psoriasis an open label one year randomized control trial in a tertiary care hospital
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare the efficacy of oral tofacitinib versus oral methotrexate in case of palmoplantar psoriasis.
研究概览
简要总结
-
All patients with clinically diagnosed cases of palmoplanter psoriasis attending KLES Dr. Prabhakar Hospital and Medical Research Centre, Belagavi will be recruited.
-
Informed consent will be taken from all the patients included in the study.
-
All patients in study will undergo a detailed history taking, general physical, systemic and dermatological examination.
-
Data will be collected by a single examiner and recorded in case record proforma.
-
Patients will be explained about the treatment offered in terms of expected results, duration of treatment, follow-ups, side effects to be reported, and prognosis of treatment.
-
Digital photographs of both palm and sole will be taken using identical camera settings, patients positioning and room lighting at baseline and at every sitting.
-
The process will be repeated every 4 weeks for a period of 12 weeks or >75% improvement in m-PPPASI score of the patient.
-
The list of side effects reported during the course of treatment will be treated accordingly.
-
After 12 weeks digital photographs will be compared with that at the baseline.
-
Patient’s assessment of improvement will also be recorded for all patients.
-
Physician’s assessment will be classified as excellent, good, and poor. The improvement will be rated as poor, good, and excellent depending on the change in patient’s disease improvement.
-
Patient’s perceptions of improvement will be noted by using the visual analogue scale, where the patient was asked to mark on the line the point that they feel represents their perception of their current state.
-
Differences in final improvement by physician and patient’s perceptions will be analysed at the end of 12 weeks + 1 week or >75% improvement in m-PPPASI score to report percentage matching as successful result of treatment.
-
Group A will be given oral methotrexate 0.3 mg/kg/week not exceeding 25 mg/week while 23 patients in Group B will be given oral tofacitinib 5 mg BD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with Palmoplantar Psoriasis confirmed by clinical correlation, dermoscopy or biopsy proven in doubtful cases.
- •Patient’s of either sex of age group 18-65 years.
- •Patients not on any other systemic medication for the same for atleast 2 months or topical treatment for the same for past 1 month.
排除标准
- •Patient having any co-morbidity such as metabolic syndrome, hypertension, diabetes mellitus, cardiovascular disease, depression, and autoimmune disease.
- •Pregnant or breast feeding women.
- •History of TB or any contact with patient of TB.
- •History of active infection like chronic liver disease, cirrhosis, HIV/AIDS, renal dysfunction or blood disorders.
- •Previous hypersensitivity recorded to Tofacitinib/methotrexate.
- •Any other dermatitis on palm and sole.
- •Patients on immunosuppressive therapy like azathioprine, cyclosporine, mycophenolate mofetil, etc for any other medical condition.
- •Patient on concomitant medications such as ketoconazole, fluconazole, rifampicin.
结局指标
主要结局
To compare the efficacy of oral tofacitinib versus oral methotrexate in case of palmoplantar psoriasis.
时间窗: one year
次要结局
- To determine the safety of oral tofacitinib versus oral methotrexate in case of palmoplantar psoriasis.(one year)
研究者
Dr Gantvya Krishna
Jawaharlal Nehru Medical College, Belagavi