xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05984381</url>
    </required_header>
    <id_info>
      <org_study_id>AIIMS BBSR/PG Thesis/2023-23</org_study_id>
      <nct_id>NCT05984381</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid</brief_title>
    <official_title>Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>All India Institute of Medical Sciences, Bhubaneswar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>All India Institute of Medical Sciences, Bhubaneswar</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Bullous pemphigoid (BP) is an autoimmune subepidermal blistering disorder most commonly&#xD;
        affecting the older population between 60-80 years old. The characteristic feature of BP is&#xD;
        itchy patches associated with blisters and erosions. BP significantly affects the patient's&#xD;
        quality of life as it causes physical discomfort with itchy patches, blisters, and erosions.&#xD;
        Several pieces of evidence from previous studies showed that the production of autoantibodies&#xD;
        against the hemidesmosomal anchoring proteins BP180 (Bullous Pemphigoid antigen (BPAG 2)) and&#xD;
        BP230 (BPAG 1) is the most common cause for bullous pemphigoid.&#xD;
  &#xD;
        Therapeutic latency, lack of efficacy in many patients, and adverse drug reactions are the&#xD;
        primary concerns in the current bullous pemphigoid treatment paradigm, including high-dose&#xD;
        steroid treatment. To overcome these treatment challenges, combination therapy with agents&#xD;
        having a steroid-sparing effect like mycophenolate mofetil, cyclophosphamide, azathioprine,&#xD;
        and Methotrexate are tested as an add-on to low-dose steroids. 8So other immunosuppressive&#xD;
        agents with better safety profiles and more efficacy, like Dapsone and Methotrexate as an&#xD;
        add-on to low-dose steroids, can be used.&#xD;
  &#xD;
        Investigator's literature search found no randomized controlled trial with Dapsone versus&#xD;
        Methotrexate as an add-on to first-line steroid has been conducted to compare the efficacy&#xD;
        and safety in bullous pemphigoid patients. So, a randomized controlled trial has been planned&#xD;
        to evaluate the safety and efficacy of add-on methotrexate versus Dapsone in bullous&#xD;
        pemphigoid patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>randomized, add-on, active-controlled, open-label, parallel-design clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>change in BPDAI (Bullous Pemphigoid Disease Area Index) score</measure>
      <time_frame>8 weeks and 16 weeks</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>change in serum BP180</measure>
      <time_frame>16 weeks</time_frame>
      <description>change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the remission rate</measure>
      <time_frame>8 weeks and 16 weeks</time_frame>
      <description>remission is defined as complete subsidence of all lesions without prednisolone or minimal prednisolone dose of 10 mg or less</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the cumulative prednisolone dose</measure>
      <time_frame>16 weeks</time_frame>
      <description>cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to the initial flare</measure>
      <time_frame>16 weeks</time_frame>
      <description>time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of flares in study groups</measure>
      <time_frame>16 weeks</time_frame>
      <description>number of flares in study groups after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>change in the Dermatological life quality index (DLQI)</measure>
      <time_frame>8 weeks and 16 weeks</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>treatment-emergent adverse events</measure>
      <time_frame>16 weeks</time_frame>
      <description>treatment-emergent adverse events in both the groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">62</enrollment>
    <condition>Bullous Pemphigoid</condition>
    <arm_group>
      <arm_group_label>Prednisolone and Methotrexate (Control Arm)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prednisolone and Dapsone (Test Arm)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Prednisolone</intervention_name>
      <description>prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally</description>
      <arm_group_label>Prednisolone and Dapsone (Test Arm)</arm_group_label>
      <arm_group_label>Prednisolone and Methotrexate (Control Arm)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dapsone</intervention_name>
      <description>Dapsone 100 mg/day</description>
      <arm_group_label>Prednisolone and Dapsone (Test Arm)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methotrexate</intervention_name>
      <description>Methotrexate 15 mg weekly</description>
      <arm_group_label>Prednisolone and Methotrexate (Control Arm)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged ≥18 of either sex with the clinical diagnosis of Bullous pemphigoid.&#xD;
  &#xD;
            -  Patients with BPDAI score ≥ 20 (moderate and severe BP).&#xD;
  &#xD;
            -  Patients must have characteristic clinical features of bullous pemphigoid at the&#xD;
               screening and baseline visits. (Urticaria, bullae, pruritis).&#xD;
  &#xD;
            -  Patients who are willing to give informed written consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients on any steroid-sparing agents within one month of recruitment.&#xD;
  &#xD;
            -  Treatment with a systemic corticosteroid, sulfones, within the last week.&#xD;
  &#xD;
            -  Patients with Glucose 6 phosphate dehydrogenase deficiency.&#xD;
  &#xD;
            -  Decreased liver or renal function (creatinine &gt; 2.0mg/dl, total bilirubin &gt; 2.5&#xD;
               mg/dl).&#xD;
  &#xD;
            -  Severe acute infection, severe diabetes mellitus, untreated glaucoma, congenital or&#xD;
               acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe&#xD;
               cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or&#xD;
               depression.&#xD;
  &#xD;
            -  Malignancies treated by cytotoxic or immunosuppressive medications.&#xD;
  &#xD;
            -  Anaemia (Hb &lt;9 gm/dl), leucopenia (&lt; 3 ×10 9 cells /L) or thrombocytopenia (&lt; 100 × 10&#xD;
               9 cells/ L), and H/O porphyria.&#xD;
  &#xD;
            -  Patient with a history of hypersensitivity to Methotrexate or Dapsone.&#xD;
  &#xD;
            -  Vaccination in the last two weeks.&#xD;
  &#xD;
            -  Patients with HIV, Hepatitis B, and C infection.&#xD;
  &#xD;
            -  Pregnancy and lactation, women of childbearing age without effective contraception.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rituparna Maiti, MD</last_name>
      <role>Study Director</role>
      <affiliation>Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monalisa Jena, MD</last_name>
      <phone>9438884193</phone>
      <email>pharm_monalisa@aiimsbhubaneswar.edu.in</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Biswanath Behera, MD</last_name>
      <phone>7978351200</phone>
      <email>Dermat_biswanath@aiimsbhubaneswar.edu.in</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>AIIMS Bhubaneswar</name>
        <address>
          <city>Bhubaneswar</city>
          <state>Odisha</state>
          <zip>751019</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Monalisa Jena, MD</last_name>
        <phone>9438884193</phone>
        <email>pharm_monalisa@aiimsbhubaneswar.edu.in</email>
      </contact>
      <investigator>
        <last_name>Biswanath Behera</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Madhusmita Sethy</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Richardson M</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>35080093</PMID>
    </reference>
    <reference>
      <citation>Chen 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.</citation>
      <PMID>35427358</PMID>
    </reference>
    <reference>
      <citation>Genovese 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.</citation>
      <PMID>31312206</PMID>
    </reference>
    <reference>
      <citation>Patton 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.</citation>
      <PMID>18665656</PMID>
    </reference>
    <reference>
      <citation>Tirado-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.</citation>
      <PMID>21497011</PMID>
    </reference>
    <reference>
      <citation>Sticherling 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.</citation>
      <PMID>28494097</PMID>
    </reference>
    <reference>
      <citation>Rashid 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.</citation>
      <PMID>31313078</PMID>
    </reference>
    <reference>
      <citation>Reunala 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.</citation>
      <PMID>26059085</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>All India Institute of Medical Sciences, Bhubaneswar</investigator_affiliation>
      <investigator_full_name>Dr. Monalisa Jena, M.D.</investigator_full_name>
      <investigator_title>Additional Professor</investigator_title>
    </responsible_party>
    <keyword>Bullous pemphigoid</keyword>
    <keyword>Methotrexate</keyword>
    <keyword>Dapsone</keyword>
    <keyword>BP180</keyword>
    <keyword>Blister</keyword>
    <keyword>Erosions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pemphigoid, Bullous</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dapsone</mesh_term>
      <mesh_term>Prednisolone</mesh_term>
      <mesh_term>Methotrexate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05984381
  org study id: AIIMS BBSR/PG Thesis/2023-23
  nct id: NCT05984381
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized, add-on, active-controlled, open-label, parallel-design clinical trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: change in BPDAI (Bullous Pemphigoid Disease Area Index) score
  time frame: 8 weeks and 16 weeks
  description: 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
  measure: change in serum BP180
  time frame: 16 weeks
  description: change in serum BP180 after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
  measure: the remission rate
  time frame: 8 weeks and 16 weeks
  description: remission is defined as complete subsidence of all lesions without prednisolone or minimal prednisolone dose of 10 mg or less
  measure: the cumulative prednisolone dose
  time frame: 16 weeks
  description: cumulative prednisolone dose after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
  measure: time to the initial flare
  time frame: 16 weeks
  description: time to the initial flare after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
  measure: number of flares in study groups
  time frame: 16 weeks
  description: number of flares in study groups after treatment with prednisolone and methotraxate Vs Prednisolone and dapsone
  measure: change in the Dermatological life quality index (DLQI)
  time frame: 8 weeks and 16 weeks
  description: 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.
  measure: treatment-emergent adverse events
  time frame: 16 weeks
  description: treatment-emergent adverse events in both the groups
  arm group label: Prednisolone and Methotrexate (Control Arm)
  arm group type: Active Comparator
  description: prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Methotrexate 15 mg weekly for 16 weeks.
  arm group label: Prednisolone and Dapsone (Test Arm)
  arm group type: Experimental
  description: prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) and Dapsone 100 mg/day for 16 weeks
  intervention type: Drug
  intervention name: Prednisolone
  description: prednisolone 0.75mg/kg/day (a maximum dose of 40mg at baseline) orally
  arm group label: Prednisolone and Dapsone (Test Arm)
  arm group label: Prednisolone and Methotrexate (Control Arm)
  intervention type: Drug
  intervention name: Dapsone
  description: Dapsone 100 mg/day
  arm group label: Prednisolone and Dapsone (Test Arm)
  intervention type: Drug
  intervention name: Methotrexate
  description: Methotrexate 15 mg weekly
  arm group label: Prednisolone and Methotrexate (Control Arm)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rituparna Maiti, MD
  role: Study Director
  affiliation: Professor
  last name: Monalisa Jena, MD
  phone: 9438884193
  email: pharm_monalisa@aiimsbhubaneswar.edu.in
  last name: Biswanath Behera, MD
  phone: 7978351200
  email: Dermat_biswanath@aiimsbhubaneswar.edu.in
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: India
  citation: 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.
  PMID: 35080093
  citation: Chen 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.
  PMID: 35427358
  citation: Genovese 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.
  PMID: 31312206
  citation: Patton 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.
  PMID: 18665656
  citation: Tirado-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.
  PMID: 21497011
  citation: Sticherling 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.
  PMID: 28494097
  citation: Rashid 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.
  PMID: 31313078
  citation: Reunala 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.
  PMID: 26059085
  responsible party type: Principal Investigator
  investigator affiliation: All India Institute of Medical Sciences, Bhubaneswar
  investigator full name: Dr. Monalisa Jena, M.D.
  investigator title: Additional Professor
  mesh term: Pemphigoid, Bullous
  mesh term: Dapsone
  mesh term: Prednisolone
  mesh term: Methotrexate
  sharing ipd: No