Health Condition 1: L20-L30- Dermatitis and eczema
Conditions
Interventions
Intervention1: Oral Tofacitnib: Oral Tofacitinib 5 mg twice daily.
Control Intervention1: Oral Methotrexate: Oral Methotrexate 0.5 mg/kg/week (maximum 25 mg/week) along with Folic acid 5 mg
once weekl
Sponsors
Department of Dermatology,Venereology and Leprology , PGIMER Chandigarh.
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults aged 18 to 60 years. 2 Clinical diagnosis of chronic hand eczema that is eczema predominantly affecting the hands, with duration of more than 3 months or at least 2 relapses in 12 months. 3 Moderate to severe disease warranting systemic therapy, defined as HECSI more than 16 and,or IGA CHE more than or equal to 3 moderate , with substantial impact on daily function. 4 Inadequate response to optimized topical therapy that is high potency corticosteroids with emollients, with or without phototherapy or skin protection. 5 Washout or stability that is prior systemic immunosuppressants or phototherapy must be discontinued for at least 4 weeks, and topical corticosteroids for at least 2 weeks, before recruitment while emollients are permitted. 6 Ability and willingness to comply with visits, photography, blood tests, and questionnaires. 7 Written informed consent.
Exclusion criteria
Exclusion criteria: 1 Pregnancy or lactation, positive pregnancy test at screening, women of childbearing potential and male participants unwilling to use effective contraception during treatment and for the recommended post-treatment duration up to 3 months. 2 Significant hepatic or renal impairment defined as AST or ALT more than two times the upper limit of normal or estimated glomerular filtration rate less than 30 mL per minute. 3 Hematologic abnormalities including absolute neutrophil count less than 1500 per microliter, absolute lymphocyte count less than 500 per microliter, platelet count less than 100,000 per microliter, or hemoglobin less than 9 grams per deciliter. 4 Infections including tuberculosis, hepatitis B or C infection, untreated HIV infection, or other serious or recurrent infections. Patients with positive IGRA or Mantoux test will be excluded. 5 History of malignancy. 6 Concurrent use of systemic immunosuppressants or biologic agents without an adequate washout period. 7 Known hypersensitivity or contraindication to tofacitinib or methotrexate or their excipients including classic methotrexate contraindications such as chronic liver disease, significant alcohol use disorder, or bone marrow suppression. 8 Confounding dermatoses involving the hands such as palmar psoriasis that may interfere with clinical assessment. 9 Anticipated poor adherence or inability to comply with study visits, investigations, or follow-up requirements. 10 High risk of thromboembolism or major adverse cardiovascular events including prior history of deep vein thrombosis or pulmonary embolism, history of myocardial infarction, stroke, or heart failure NYHA class III or IV, known inherited or acquired thrombophilia, or recent major surgery or prolonged immobilization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients in both study groups achieving HECSI 75 (more than equal to 75 percent reduction from baseline) at Week 12.Timepoint: Achievement of HECSI 75 will be determined at Week 12 and HECSI will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare efficacy between the two groups using change in HECSI from baseline to Week 12, and time to achieve HECSI-50.Timepoint: HECSI assessed at baseline, 4 weeks, 8 weeks & 12 weeks ; time to achieve HECSI 50 checked at each visit).;To compare global clinical response & patient-reported outcomes between groups using IGA- CHE 0/1 at Week 12, DLQI change, & Itch NRS change from baseline to Week 12.Timepoint: IGA CHE , DLQI & Itch NRS will be assessed at baseline, 4 weeks, 8 weeks & 12 weeks.IGA-CHE 0/1 achievement will be checked at Week 12).;To assess safety & tolerability by comparing adverse events, laboratory abnormalities, and treatment discontinuation up to Week 12.Timepoint: Assessment of safety & tolerability (adverse events, laboratory parameters, & treatment discontinuation) will be performed at baseline, 4 weeks, 8 weeks & 12 weeks, with ongoing monitoring throughout the study duration. | — |
Countries
India
Contacts
Public ContactDr Ishita Shukla
Postgraduate Institute of Medical Education and Research , Chandigarh
Outcome results
None listed