Clinical Trials Logo
  1. Home
  2. Bullous Pemphigoid
  3. NCT05984381

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

Bullous Pemphigoid Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05984381
Study type Interventional
Source All India Institute of Medical Sciences, Bhubaneswar
Contact Monalisa Jena, MD
Phone 9438884193
Email pharm_monalisa@aiimsbhubaneswar.edu.in
Status Recruiting
Phase Phase 4
Start date August 1, 2023
Completion date December 1, 2024
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03286582 - A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid Phase 2
Completed NCT02837965 - Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid
Recruiting NCT03636763 - Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?
Recruiting NCT00802243 - Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid Phase 2
Completed NCT05649579 - Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
Active, not recruiting NCT04206553 - A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid Phase 2/Phase 3
Completed NCT00431119 - Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid Phase 2
Completed NCT04563923 - Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody Phase 2
Completed NCT03320798 - Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients N/A
Completed NCT03272958 - Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
Completed NCT02883894 - Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid N/A
Completed NCT00809822 - Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids. Phase 2
Recruiting NCT05594472 - Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid Phase 3
Withdrawn NCT05061771 - Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP) Phase 3
Not yet recruiting NCT04128176 - Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid Phase 3
Recruiting NCT05284929 - Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Terminated NCT04612790 - A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. Phase 3
Recruiting NCT05681481 - A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid Phase 3
Completed NCT00286325 - Rituximab in the Treatment of Patients With Bullous Pemphigoid Phase 1/Phase 2
Completed NCT04728854 - Telederm and Bullous Pemphigoid