Status:
COMPLETED
Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disorder most commonly affecting the older population between 60-80 years old. The characteristic feature of BP is itchy patches associ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05984381
Start Date
August 1 2023
End Date
April 1 2025
Last Update
August 14 2025
Active Locations (1)
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1
AIIMS Bhubaneswar
Bhubaneswar, Odisha, India, 751019