Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- change in BPDAI (Bullous Pemphigoid Disease Area Index) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prednisolone and Methotrexate (Control Arm)
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks.
干预措施: Prednisolone (Drug)
Prednisolone and Methotrexate (Control Arm)
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks.
干预措施: Methotrexate (Drug)
Prednisolone and Dapsone (Test Arm)
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks
干预措施: Prednisolone (Drug)
Prednisolone and Dapsone (Test Arm)
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks
干预措施: Dapsone (Drug)
结局指标
主要结局
change in BPDAI (Bullous Pemphigoid Disease Area Index) score
时间窗: 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
次要结局
- change in serum BP180(16 weeks)
- the remission rate(8 weeks and 16 weeks)
- the cumulative prednisolone dose(16 weeks)
- time to the initial flare(16 weeks)
- number of flares in study groups(16 weeks)
- change in the Dermatological life quality index (DLQI)(8 weeks and 16 weeks)
- treatment-emergent adverse events(16 weeks)
研究者
Dr. Monalisa Jena, M.D.
Additional Professor
All India Institute of Medical Sciences, Bhubaneswar