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

Last updated: August 13, 2025
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Overall Status: Completed

Phase

4

Condition

Pemphigus Vulgaris (Pv)

Epidermolysis Bullosa

Treatment

Methotrexate

Dapsone

Prednisolone

Clinical Study ID

NCT05984381
AIIMS BBSR/PG Thesis/2023-24
  • Ages > 18
  • All Genders

Study 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 associated with blisters and erosions. BP significantly affects the patient's quality of life as it causes physical discomfort with itchy patches, blisters, and erosions. Several pieces of evidence from previous studies showed that the production of autoantibodies against the hemidesmosomal anchoring proteins BP180 (Bullous Pemphigoid antigen (BPAG 2)) and BP230 (BPAG 1) is the most common cause for bullous pemphigoid.

Therapeutic latency, lack of efficacy in many patients, and adverse drug reactions are the primary concerns in the current bullous pemphigoid treatment paradigm, including high-dose steroid treatment. To overcome these treatment challenges, combination therapy with agents having a steroid-sparing effect like mycophenolate mofetil, cyclophosphamide, azathioprine, and Methotrexate are tested as an add-on to low-dose steroids. 8So other immunosuppressive agents with better safety profiles and more efficacy, like Dapsone and Methotrexate as an add-on to low-dose steroids, can be used.

Investigator's literature search found no randomized controlled trial with Dapsone versus Methotrexate as an add-on to first-line steroid has been conducted to compare the efficacy and safety in bullous pemphigoid patients. So, a randomized controlled trial has been planned to evaluate the safety and efficacy of add-on methotrexate versus Dapsone in bullous pemphigoid patients.

Eligibility Criteria

Inclusion

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 thescreening and baseline visits. (Urticaria, bullae, pruritis).

  • Patients who are willing to give informed written consent.

Exclusion

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 > 2.5mg/dl).

  • Severe acute infection, severe diabetes mellitus, untreated glaucoma, congenital oracquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severecardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia ordepression.

  • 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.

Study Design

Total Participants: 62
Treatment Group(s): 3
Primary Treatment: Methotrexate
Phase: 4
Study Start date:
August 01, 2023
Estimated Completion Date:
April 01, 2025

Connect with a study center

  • AIIMS Bhubaneswar

    Bhubaneswar, Odisha 751019
    India

    Site Not Available

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