Comparing Dapsone and Methotrexate for treating Bullous Pemphigoid
Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial
This study is trying to see if adding Dapsone to treatment works better than Methotrexate for adults with moderate to severe Bullous Pemphigoid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Drugs / interventions | Methotrexate, cyclophosphamide |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT05984381 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Dapsone as an add-on treatment compared to Methotrexate in patients diagnosed with Bullous Pemphigoid, an autoimmune blistering disorder. The study aims to address treatment challenges such as therapeutic latency and adverse drug reactions associated with current therapies, particularly high-dose steroids. Patients aged 18 and older with moderate to severe Bullous Pemphigoid will be recruited, and their responses to the two medications will be monitored. The trial is conducted at the All India Institute of Medical Sciences in Bhubaneswar, Odisha.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of moderate to severe Bullous Pemphigoid.
Not a fit: Patients currently on steroid-sparing agents or with certain severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients suffering from Bullous Pemphigoid.
How similar studies have performed: Previous studies have explored various treatments for Bullous Pemphigoid, but the specific comparison of Dapsone and Methotrexate is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bhubaneswar, Odisha
- AIIMS Bhubaneswar — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Study coordinator: Monalisa Jena, MD
- Email: pharm_monalisa@aiimsbhubaneswar.edu.in
- Phone: 9438884193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.