A prospective, comparative, randomized study on efficacy, safety of oral methotrexate vs oral tofacitinib in management of palmoplantar psoriasis.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) score specifically for the palmoplantar regions, from baseline to the end of the treatment period.
研究概览
简要总结
PALMOPLANTAR PSORIASIS IS A PERSISTENT INFLAMMATORY SKIN CONDITION CHARACTERISIED BY THE APPEARANCE OF THICKENED SCALY PLAQUES ON THE PALMS AND SOLES. THE CONDITION IS OFTEN RESISTANT TO CONVENTIONAL TOPICAL TREATMENTS SIGNIFICANTLLY IMPACTING THE PATIENT’S QUALITY OF LIFE AND LEADING TO BOTH PHYSICAL DISCOMFORT AND SOCIAL STIGMA. THE VARIABILITY IN TREATMENT RESPONSE NECESSITATIES ONGOING REASEARCH INTO MORE EFFECTIVE THERAPEUTIC STRATAGIES.
THIS PROSPECTIVE, COMPARATIVE, RANDOMISED CLINICAL STUDY AIMS TO EVALUATE THE EFFICACY, SAFETY OF ORAL METHOTREXATE VS ORAL TOFACITINIB IN THE MANAGEMENT OF PALMOPLANTAR PSORIASIS. CONDUCTED IN THE DEPARTMENT OF DERMATOLOGY, VENEREOLOGY, LEPROLOGY AT A TERTIARY CARE CENTRE IN MAHARASHTRA, THE STUDY WILL ENLIST PATIENTS WHO MEET THE INCLUSION CRITERIA AND DIVIDE THEM INTO TWO TREATMENT GROUPS. GROUP A WILL RECEIVE ORAL METHOTREXATE, DOSED ACCORDING TO BODY WEIGHT FOR A PERIOD OF 12 WEEKS. GROUP B WILL BE GIVEN ORAL TOFACITINIB 5MG TWICE DAILY FOR THE SAME DURATION. THE PRIMARY OUTCOME WILL BE THE CHANGE IN MODIFIED PALMOPLANTAR PSORIASIS AREA AND SEVERITY SCORE ( MPPPASI ) FROM BASELINE TO THE END OF TREATMENT, WITH A FOLLOW UP PERIOD OF 3 MONTHS TO ASSESS THE DURABILITY OF CLINICAL RESPONSE AND TO MONITOR FOR POTENTIAL RECURRENCE OR SIDE EFFECTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult aged more than 18 years and less than 60 years 2)Confirmed case of palmoplantar psoriasis by skin punch biopsy.
- •History of palmoplantar psoriasis for atleast 6 months.
- •Both male and female.
排除标准
- •Age less than 18years and more than 60 years.
- •Patient with nail psoriasis and psoriatic arthropathy.
- •Patient unwilling to give consent.
- •Patient with anemia and infections GI disease, respiratory diseases.
- •history of recent live vaccination 7)Patient with co-morbidities.
- •Alcohol consumption, tobacco and smoking.
- •Organ transplant.
- •Patient with thromboembolism, stroke, cardiovascular disease.
结局指标
主要结局
The primary endpoint will be the improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) score specifically for the palmoplantar regions, from baseline to the end of the treatment period.
时间窗: baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months.
次要结局
- Secondary endpoints will include patient-reported outcomes on pain and discomfort, quality of life measures, and a comprehensive safety profile assessment including laboratory monitoring for potential drug-related adverse effects.(baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months)
研究者
KIRTI NITIN HAJARE
Shri bhuasaheb hire government medical college, dhule
