Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid
Bullous Pemphigoid
About this trial
This is an interventional treatment trial for Bullous Pemphigoid focused on measuring Bullous pemphigoid, Methotrexate, Dapsone, BP180, Blister, Erosions
Eligibility Criteria
Inclusion Criteria: Patients aged ≥18 of either sex with the clinical diagnosis of Bullous pemphigoid. Patients with BPDAI score ≥ 20 (moderate and severe BP). Patients must have characteristic clinical features of bullous pemphigoid at the screening and baseline visits. (Urticaria, bullae, pruritis). Patients who are willing to give informed written consent. Exclusion Criteria: Patients on any steroid-sparing agents within one month of recruitment. Treatment with a systemic corticosteroid, sulfones, within the last week. Patients with Glucose 6 phosphate dehydrogenase deficiency. Decreased liver or renal function (creatinine > 2.0mg/dl, total bilirubin > 2.5 mg/dl). Severe acute infection, severe diabetes mellitus, untreated glaucoma, congenital or acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or depression. Malignancies treated by cytotoxic or immunosuppressive medications. Anaemia (Hb <9 gm/dl), leucopenia (< 3 ×10 9 cells /L) or thrombocytopenia (< 100 × 10 9 cells/ L), and H/O porphyria. Patient with a history of hypersensitivity to Methotrexate or Dapsone. Vaccination in the last two weeks. Patients with HIV, Hepatitis B, and C infection. Pregnancy and lactation, women of childbearing age without effective contraception.
Sites / Locations
- AIIMS BhubaneswarRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Prednisolone and Methotrexate (Control Arm)
Prednisolone and Dapsone (Test Arm)
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks.
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks