Bullous PemphigoidPhase 4NCT05984381
Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid
A Phase 4 study testing Prednisolone, Dapsone and Methotrexate in people with Bullous Pemphigoid, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Prednisolone, Dapsone and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2023to 1 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bullous Pemphigoid
- Being tested
- Prednisolone, Dapsone, Methotrexate
- Keywords
- Bullous pemphigoid, Methotrexate, Dapsone, BP180, Blister, Erosions
- Medical subject headings
- Pemphigoid, Bullous, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally
DapsoneDrug
Dapsone 100 mg/day
MethotrexateDrug
Methotrexate 15 mg weekly
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone and Methotrexate (Control Arm) | Active comparator | prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks. Receives: Drug: Prednisolone; Drug: Methotrexate |
| Prednisolone and Dapsone (Test Arm) | Experimental | prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks Receives: Drug: Prednisolone; Drug: Dapsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks and 16 weeks
Secondary outcomes (7)
change in serum BP180
change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Measured: 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
Measured: 8 weeks and 16 weeks
the cumulative prednisolone dose
cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Measured: 16 weeks
time to the initial flare
time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Measured: 16 weeks
number of flares in study groups
number of flares in study groups after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
Measured: 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.
Measured: 8 weeks and 16 weeks
treatment-emergent adverse events
treatment-emergent adverse events in both the groups
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2023
- Primary completion3 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, add-on, active-controlled, open-label, parallel-design clinical trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Monalisa Jena, M.D., All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Rituparna Maiti, MD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984381
- Sponsor's protocol ID
- AIIMS BBSR/PG Thesis/2023-24
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu L, Chen L, Xu Y, Liu A. Global incidence and prevalence of bullous pemphigoid: A systematic review and meta-analysis. J Cosmet Dermatol. 2022 Oct;21(10):4818-4835. doi: 10.1111/jocd.14797. Epub 2022 Feb 1.
PubMed 35080093Chen X, Zhang Y, Luo Z, Wu Y, Niu T, Zheng J, Xie Y. Prognostic factors for mortality in bullous pemphigoid: A systematic review and meta-analysis. PLoS One. 2022 Apr 15;17(4):e0264705. doi: 10.1371/journal.pone.0264705. eCollection 2022.
PubMed 35427358Genovese G, Di Zenzo G, Cozzani E, Berti E, Cugno M, Marzano AV. New Insights Into the Pathogenesis of Bullous Pemphigoid: 2019 Update. Front Immunol. 2019 Jul 2;10:1506. doi: 10.3389/fimmu.2019.01506. eCollection 2019.
PubMed 31312206Patton T, Korman N. Role of methotrexate in the treatment of bullous pemphigoid in the elderly. Drugs Aging. 2008;25(8):623-9. doi: 10.2165/00002512-200825080-00001.
PubMed 18665656Tirado-Sanchez A, Diaz-Molina V, Ponce-Olivera RM. Efficacy and safety of azathioprine and dapsone as an adjuvant in the treatment of bullous pemphigoid. Allergol Immunopathol (Madr). 2012 May-Jun;40(3):152-5. doi: 10.1016/j.aller.2010.12.009. Epub 2011 Apr 14.
PubMed 21497011Sticherling M, Franke A, Aberer E, Glaser R, Hertl M, Pfeiffer C, Rzany B, Schneider S, Shimanovich I, Werfel T, Wilczek A, Zillikens D, Schmidt E. An open, multicentre, randomized clinical study in patients with bullous pemphigoid comparing methylprednisolone and azathioprine with methylprednisolone and dapsone. Br J Dermatol. 2017 Nov;177(5):1299-1305. doi: 10.1111/bjd.15649. Epub 2017 Oct 29.
PubMed 28494097Rashid H, Lamberts A, Diercks GFH, Pas HH, Meijer JM, Bolling MC, Horvath B. Oral Lesions in Autoimmune Bullous Diseases: An Overview of Clinical Characteristics and Diagnostic Algorithm. Am J Clin Dermatol. 2019 Dec;20(6):847-861. doi: 10.1007/s40257-019-00461-7.
PubMed 31313078Reunala T, Salmi TT, Hervonen K. Dermatitis herpetiformis: pathognomonic transglutaminase IgA deposits in the skin and excellent prognosis on a gluten-free diet. Acta Derm Venereol. 2015 Nov;95(8):917-22. doi: 10.2340/00015555-2162.
PubMed 26059085
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05984381
- Acronym / sponsor ID
- AIIMS BBSR/PG Thesis/2023-24
- Conditions
- Bullous Pemphigoid
- Keywords
- Bullous pemphigoid, Methotrexate, Dapsone, BP180, Blister, Erosions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, add-on, active-controlled, open-label, parallel-design clinical trial
| Arm | Type | Receives |
|---|---|---|
| Prednisolone and Methotrexate (Control Arm) | Active comparator | Drug: Prednisolone, Drug: Methotrexateprednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks. |
| Prednisolone and Dapsone (Test Arm) | Experimental | Drug: Prednisolone, Drug: Dapsoneprednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisoloneprednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally | Drug | Prednisolone and Dapsone (Test Arm), Prednisolone and Methotrexate (Control Arm) |
| DapsoneDapsone 100 mg/day | Drug | Prednisolone and Dapsone (Test Arm) |
| MethotrexateMethotrexate 15 mg weekly | Drug | Prednisolone and Methotrexate (Control Arm) |
Primary outcome
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
7 secondary outcomes
change in serum BP180
Time frame: 16 weeks
the remission rate
Time frame: 8 weeks and 16 weeks
the cumulative prednisolone dose
Time frame: 16 weeks
time to the initial flare
Time frame: 16 weeks
number of flares in study groups
Time frame: 16 weeks
change in the Dermatological life quality index (DLQI)
Time frame: 8 weeks and 16 weeks
treatment-emergent adverse events
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 35080093Lu L, Chen L, Xu Y, Liu A. Global incidence and prevalence of bullous pemphigoid: A systematic review and meta-analysis. J Cosmet Dermatol. 2022 Oct;21(10):4818-4835. doi: 10.1111/jocd.14797. Epub 2022 Feb 1.
- Background: PubMed 35427358Chen X, Zhang Y, Luo Z, Wu Y, Niu T, Zheng J, Xie Y. Prognostic factors for mortality in bullous pemphigoid: A systematic review and meta-analysis. PLoS One. 2022 Apr 15;17(4):e0264705. doi: 10.1371/journal.pone.0264705. eCollection 2022.
- Background: PubMed 31312206Genovese G, Di Zenzo G, Cozzani E, Berti E, Cugno M, Marzano AV. New Insights Into the Pathogenesis of Bullous Pemphigoid: 2019 Update. Front Immunol. 2019 Jul 2;10:1506. doi: 10.3389/fimmu.2019.01506. eCollection 2019.
- Background: PubMed 18665656Patton T, Korman N. Role of methotrexate in the treatment of bullous pemphigoid in the elderly. Drugs Aging. 2008;25(8):623-9. doi: 10.2165/00002512-200825080-00001.
- Background: PubMed 21497011Tirado-Sanchez A, Diaz-Molina V, Ponce-Olivera RM. Efficacy and safety of azathioprine and dapsone as an adjuvant in the treatment of bullous pemphigoid. Allergol Immunopathol (Madr). 2012 May-Jun;40(3):152-5. doi: 10.1016/j.aller.2010.12.009. Epub 2011 Apr 14.
- Background: PubMed 28494097Sticherling M, Franke A, Aberer E, Glaser R, Hertl M, Pfeiffer C, Rzany B, Schneider S, Shimanovich I, Werfel T, Wilczek A, Zillikens D, Schmidt E. An open, multicentre, randomized clinical study in patients with bullous pemphigoid comparing methylprednisolone and azathioprine with methylprednisolone and dapsone. Br J Dermatol. 2017 Nov;177(5):1299-1305. doi: 10.1111/bjd.15649. Epub 2017 Oct 29.
- Background: PubMed 31313078Rashid H, Lamberts A, Diercks GFH, Pas HH, Meijer JM, Bolling MC, Horvath B. Oral Lesions in Autoimmune Bullous Diseases: An Overview of Clinical Characteristics and Diagnostic Algorithm. Am J Clin Dermatol. 2019 Dec;20(6):847-861. doi: 10.1007/s40257-019-00461-7.
- Background: PubMed 26059085Reunala T, Salmi TT, Hervonen K. Dermatitis herpetiformis: pathognomonic transglutaminase IgA deposits in the skin and excellent prognosis on a gluten-free diet. Acta Derm Venereol. 2015 Nov;95(8):917-22. doi: 10.2340/00015555-2162.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rituparna Maiti, MD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone, Dapsone and Methotrexate in people with Bullous Pemphigoid, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in BPDAI (Bullous Pemphigoid Disease Area Index) score (time frame: 8 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05984381, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.