Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: oral tablet Tofacitinib: oral tablet Tofacitinib 5mg morning and night after food for 12 weeks
Control Intervention1: oral tablet Cyclopsorine: oral tablet cyclosporine 100mg morning an
Sponsors
Indian Association of Dermatologists, Venereologists, and Leprologists
Eligibility
Inclusion criteria
Inclusion criteria: Clinically diagnosed cases of moderate to severe prurigo nodularis
Exclusion criteria
Exclusion criteria: 1. Immunosuppressed patients 2. Pregnant and Lactating women 3. Contraindications for tofacitinib 4. Contraindications for cyclosporine 5. Not consenting for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of oral tofacitinib in comparison with cyclosporine (using pruritus grading system score and peak pruritus numerical rating scale) in the management of prurigo nodularisTimepoint: 4,8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the side effect profile between two groups. 2. To do the cost-effectiveness analysis between the 2 groups. 3. To analyze the tissue expression levels of STAT1, STAT3, and STAT6 in all patients with prurigo nodularis through immunohistochemistry markers. Timepoint: 4,8 and 12 weeks | — |
Countries
India
Contacts
Public ContactLogamoorthy R
Sri Manakula Vinayagar Medical College and Hospital, Puducherry
Outcome results
None listed