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

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ClinicalTrials.gov Identifier: NCT05984381
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Bullous Pemphigoid Drug: Prednisolone Drug: Dapsone Drug: Methotrexate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, add-on, active-controlled, open-label, parallel-design clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: Prednisolone
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally

Drug: Methotrexate
Methotrexate 15 mg weekly
Experimental: 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
 Drug: Prednisolone
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally

Drug: Dapsone
Dapsone 100 mg/day


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984381


Contacts
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Contact: Monalisa Jena, MD 9438884193 pharm_monalisa@aiimsbhubaneswar.edu.in
Contact: Biswanath Behera, MD 7978351200 Dermat_biswanath@aiimsbhubaneswar.edu.in

Locations
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India
AIIMS Bhubaneswar
Bhubaneswar, Odisha, India, 751019
Contact: Monalisa Jena, MD    9438884193    pharm_monalisa@aiimsbhubaneswar.edu.in   
Sub-Investigator: Biswanath Behera         
Sub-Investigator: Madhusmita Sethy         
Sub-Investigator: Richardson M         
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Study Director: Rituparna Maiti, MD Professor
More Information
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Publications:

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Responsible Party: Dr. Monalisa Jena, M.D., Additional Professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT05984381    
Other Study ID Numbers: AIIMS BBSR/PG Thesis/2023-23
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar:
Bullous pemphigoid
Methotrexate
Dapsone
 BP180
Blister
Erosions
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Dapsone
Prednisolone
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Infective Agents
Antimalarials