Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Oral Cyclosporine: The study group includes Patients receiving Tab. Cyclosporine.The dose,schedule and dosing regimen would be chosen by the treating dermatologist.Total duration of the
Sponsors
Department of Health Research under MoHFW
Eligibility
Inclusion criteria
Inclusion criteria: NOT APPLICABLE
Exclusion criteria
Exclusion criteria: 1. Patients with pustular, erythrodermic, and/or guttate forms of psoriasis (non-plaque forms of psoriasis). 2. Patient prescribed other systemic anti-psoriatic therapies (e.g., biologics, retinoids) in combination with methotrexate or cyclosporine. 3. Patients with a history of hypersensitivity or allergic reactions to cyclosporine or methotrexate. 4. Patients with a history of malignancy or current malignancy. 5. Patients with a history suggestive of pregnancy. 6. Patients with a history of significant liver or renal impairment. 7. Patients in view of treating dermatologists may not be the suitable candidate for methotrexate or cyclosporin therapy due to any other factor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in PASI (Psoriasis Area and severity index) score at week 16Timepoint: 1. Baseline (start of treatment) 2. Follow up (4th, 8th, 12th weeks after initiation) 3. End of treatment (12 weeks afterinitiation) Follow-up assessments at 4, 8, 12weeks and 16weeks post-treatment to evaluate effedtiveness by seeing imrpovement in Psoriasis Area and severity index score | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients attaining PASI 75 (Psoriasis Area and Severity Index) at the end of 16 weeksTimepoint: Psoriasis Area and severity index score at the end of treatment (after 16 weeks from initiation);Proportion of patients achieving good adherence to cyclosporine and methotrexate, defined as an Simplified Medication Adherence Questionnaire(SMAQ) score 0, at the end of 16 weeks.Timepoint: Simplified Medication Adherence Questionnaire score at the end of treatment (after 16 weeks from initiation) | — |
Countries
India
Contacts
Public ContactDr Devapandian M
Government Medical College, Nagpur
Outcome results
None listed