Health Condition 1: L281- Prurigo nodularis
Conditions
Interventions
Intervention1: Oral tablet Tofacitinib 5mg: twice daily, for 6 months.
25 patients will be given Tofacitinib
Parallel study, no cross over
Control Intervention1: Tablet Methotrexate 15mg: once weekly
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: All the patients of CNPG of both sexes who are more than 18 years of age with minimum of 6 pruriginous lesions and willing to give informed written consent
Exclusion criteria
Exclusion criteria: CNPG associated with chronic renal failure, liver disease, cardiovascular disease, diabetes mellitus, contact dermatitis, malignancy, and HIV infection Patients with active atopic dermatitis other than CNPG lesions renal disease, and severe hypertriglyceridemia Patients with known immunosuppression or on immunosuppressive therapy Patients on oral contraceptive Pregnant and lactating participants Hypersensitivity documented to the prescribed drugs Patients on therapy that interacts with interventional drugs Participants with BMI more than 40 kg per metre square Patients with underlying psychiatric disorders and on therapy will be excluded Patients who have been treated with topical or intralesional corticosteroids within two weeks before randomization Patients on systemic glucocorticoids, methotrexate, or other immunosuppressive drugs within four weeks before randomization Patients who have received prior oral JAK inhibitors Anemia, Leukopenia, or thrombocytopenia, active liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in IGA for CNPG between the two groupsTimepoint: at week 12 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients achieving well-controlled CNPG, defined by a PCT score of ââ?°Â¥ 10, between the two groups at week 12 and 24 2. Reduction in NRS itch and sleeplessness score intensity between the groups at week 12 and 24 3. Relapse rate, defined by the appearance of 1-5 new pruriginous lesions at weeks 12 and 24, between two groups 4. Comparison of reduction in DLQI at weeks 12 and 24 between two groups 5. Cumulative dose of rescue bilastine between the group at weeks 12 and 24 6. 50% and 100% reduction in NRS itch scoreTimepoint: 3 months and 6 months | — |
Countries
India
Contacts
Public ContactFarhan Sayed Riyaz Ahmed Khatib
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed