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NCT Number: NCT05984381

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

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.

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Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Blister Immune System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIIMS Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally

Dapsone

Drug

Dapsone 100 mg/day

methotrexate

Drug

Methotrexate 15 mg weekly

Primary outcomes

  1. change in BPDAI (Bullous Pemphigoid Disease Area Index) score

    Time frame: 8 weeks and 16 weeks

    change in BPDAI (Bullous Pemphigoid Disease Area Index) score after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone Score range from 0-360 (Minimum 0 and maximum 360) higher scores indicating greater disease activity

Secondary outcomes

  1. change in serum BP180

    Time frame: 16 weeks

    change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone

  2. the remission rate

    Time frame: 8 weeks and 16 weeks

    remission is defined as complete subsidence of all lesions without prednisolone or minimal prednisolone dose of 10 mg or less

  3. the cumulative prednisolone dose

    Time frame: 16 weeks

    cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone

  4. time to the initial flare

    Time frame: 16 weeks

    time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone

  5. number of flares in study groups

    Time frame: 16 weeks

    number of flares in study groups after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone

  6. change in the Dermatological life quality index (DLQI)

    Time frame: 8 weeks and 16 weeks

    change in the Dermatological life quality index (DLQI) after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone maximum of 30 and a minimum of 0 The higher the score, the more quality of life is impaired.

  7. treatment-emergent adverse events

    Time frame: 16 weeks

    treatment-emergent adverse events in both the groups

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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