Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar