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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally
Dapsone 100 mg/day
Methotrexate 15 mg weekly
AIIMS Bhubaneswar
Bhubaneswar, Odisha, India
change in BPDAI (Bullous Pemphigoid Disease Area Index) score
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
Time frame: 8 weeks and 16 weeks
change in serum BP180
change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Time frame: 16 weeks
the remission rate
remission is defined as complete subsidence of all lesions without prednisolone or minimal prednisolone dose of 10 mg or less
Time frame: 8 weeks and 16 weeks
the cumulative prednisolone dose
cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Time frame: 16 weeks
time to the initial flare
time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Time frame: 16 weeks
number of flares in study groups
number of flares in study groups after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Time frame: 16 weeks
change in the Dermatological life quality index (DLQI)
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.
Time frame: 8 weeks and 16 weeks
treatment-emergent adverse events
treatment-emergent adverse events in both the groups
Time frame: 16 weeks
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