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

December 12, 2023 updated by: Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Recruiting
        • AIIMS Bhubaneswar
        • Contact:
        • Sub-Investigator:
          • Biswanath Behera
        • Sub-Investigator:
          • Madhusmita Sethy
        • Sub-Investigator:
          • Richardson M

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in serum BP180
Time Frame: 16 weeks
change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
16 weeks
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
8 weeks and 16 weeks
the cumulative prednisolone dose
Time Frame: 16 weeks
cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
16 weeks
time to the initial flare
Time Frame: 16 weeks
time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
16 weeks
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
16 weeks
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.
8 weeks and 16 weeks
treatment-emergent adverse events
Time Frame: 16 weeks
treatment-emergent adverse events in both the groups
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Investigators

  • Study Director: Rituparna Maiti, MD, professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIIMS BBSR/PG Thesis/2023-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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