Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two medications, Dapsone and Methotrexate, when added to low-dose steroids for treating bullous pemphigoid (BP), a skin condition that causes itchy patches and blisters, mainly in older adults. The goal is to find out which of these two treatments works better and has fewer side effects when used alongside steroids. Since bullous pemphigoid can seriously affect a person's quality of life, finding safer and more effective treatment options is important.

To participate in the trial, individuals must be at least 18 years old and have a moderate to severe case of bullous pemphigoid. They should have symptoms like blisters and itching, and must be willing to give informed consent to join the study. However, people who have recently taken certain other medications, have severe health issues, or are pregnant or breastfeeding, among other criteria, are not eligible. Participants will be monitored for how well the treatments work and any side effects they may experience. This study is currently recruiting, and it aims to provide valuable insights into better management of bullous pemphigoid.

Gender

ALL

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.