Psoriasis
Conditions
Keywords
MtX, Tofacitinib
Brief summary
Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study
Detailed description
Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study
Interventions
DRUGMethotrexate
Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment
DRUGTofacitinib
Tofacitinib is janus kinase inhibitor and have role in psoriasis
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18- 70 years of either gender. * Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included. * Duration of plaque psoriasis for at least 6 months prior to the study. * Psoriasis that has not shown adequate response to topical therapies
Exclusion criteria
* Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis. * Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded. * Known hypersensitivity or contraindications to either methotrexate or tofacitinib. * History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy. * Pregnant or lactating women will not be eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Achievement | Baseline to Week 12 of treatment | The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as Achieved if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and Not Achieved if this threshold is not met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Reduction in PASI Score | From Baseline to Week 12 | This outcome will quantify the degree of improvement by calculating the percentage reduction in PASI score from baseline to Week 12. Percentage reduction will be computed using the formula: \[(Baseline PASI - Week-12 PASI) ÷ Baseline PASI\] × 100. |
Countries
Pakistan
Contacts
Primary ContactMaryam Fatima, Mbbs
Outcome results
None listed