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Comparing efficacy and safety Methotrexate VS oral Tofacitinib in management of palmoplantar psoriasis.

A prospective, comparative, randomized study on efficacy, safety of oral methotrexate vs oral tofacitinib in management of palmoplantar psoriasis. - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070540
Enrollment
66
Registered
2024-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L408- Other psoriasis

Interventions

Intervention1: oral methotrexate (according to body weight): Participants in this group will receive oral methotrexate, dosed according to standard clinical guidelines ( firstly test dose of 2.5mg is

Sponsors

KIRTI NITIN HAJARE
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactKIRTI NITIN HAJARE

SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE,DHULE

drchetanrajput@yahoo.com8888487808

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026