Comparing efficacy and safety Methotrexate VS oral Tofacitinib in management of palmoplantar psoriasis.
Phase 3
- Conditions
- Health Condition 1: L408- Other psoriasis
- Registration Number
- CTRI/2024/07/070540
- Lead Sponsor
- KIRTI NITIN HAJARE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Adult aged more than 18 years and less than 60 years
2)Confirmed case of palmoplantar psoriasis by skin punch biopsy.
3)History of palmoplantar psoriasis for atleast 6 months.
4)Both male and female.
Exclusion Criteria
1)Age less than 18years and more than 60 years.
2)Patient with nail psoriasis and psoriatic arthropathy.
3)Patient unwilling to give consent.
4)Patient with anemia and infections GI disease, respiratory diseases.
5)Patient planning to have children.
6)history of recent live vaccination
7)Patient with co-morbidities.
8)Alcohol consumption, tobacco and smoking.
9)Organ transplant.
10)Patient with thromboembolism, stroke, cardiovascular disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months.
- Secondary Outcome Measures
Name Time Method 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.Timepoint: baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months