<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/NCT04469582</url>
  </required_header>
  <id_info>
    <org_study_id>BP-DPP4is</org_study_id>
    <nct_id>NCT04469582</nct_id>
  </id_info>
  <brief_title>The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors</brief_title>
  <official_title>The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors: Α Ten-year Prospective Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators conducted a prospective study which included all patients diagnosed with&#xD;
      biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and&#xD;
      December 31, 2019. 113 consecutive patients with BP were identified. The investigators&#xD;
      included the patients with type 2 diabetes and investigated the percentage of patients who&#xD;
      were under treatment with DPP4-is. The specific DPP4-i prescribed was also documented.Medical&#xD;
      information including patients' age, sex, other comorbidities and concomitant medications&#xD;
      were also recorded. Furthermore, the investigators evaluated the effect of different types of&#xD;
      treatment (topical steroids, systemic corticosteroids, immunosuppressive agents) on bullous&#xD;
      pemphigoid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bullous pemphigoid (BP) is the most common chronic autoimmune skin disease which is&#xD;
      characterized by the presentation of subepidermical blisters and mostly affects elderly&#xD;
      patients . Recent studies have suggested that dipeptidyl peptidase-4 inhibitors (DPP-4is), an&#xD;
      incretin-based drug for type 2 diabetes, as possible predisposing agents of BP . The&#xD;
      objective of the study was to estimate the association between the use of DPP-4is and the&#xD;
      development of BP in the setting of a tertiary university hospital and to raise awareness for&#xD;
      everyday clinical practice, both among dermatologists as well as all physicians following&#xD;
      patients with diabetes The study was designed as an observational prospective study.In the&#xD;
      study included all patients who received a new diagnosis of BP and hospitalized in the&#xD;
      Dermatology Department of our hospital between April 1, 2009 and December 31, 2019 Inclusion&#xD;
      Criteria included a) biopsy proven bullous pemphigoid b) severe bullous pemphigoid c) recent&#xD;
      manifestation of bullous pemphigoid (last four months).Exclusion Criteria included a) non&#xD;
      bullous pemphigoid b) presentation of bullous pemphigoid more than four months c) treatment&#xD;
      with DPP4is more than two years.&#xD;
&#xD;
      Overall, 113 consecutive patients with the diagnosis of BP were enrolled in the study.The&#xD;
      investigators reviewed the percentage of patients with type 2 diabetes among all patients&#xD;
      with BP.The number of patients who were under treatment with DPP4-is and the specific type of&#xD;
      DPP4-is prescribed were also examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 1, 2009</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 9, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid</measure>
    <time_frame>baseline</time_frame>
    <description>The investigators assessed the percentage of patients who were under treatment with DPP4-is among patients with bullous pemphigoid</description>
  </primary_outcome>
  <enrollment type="Anticipated">113</enrollment>
  <condition>Bullous Pemphigoid</condition>
  <eligibility>
    <study_pop>
      <textblock>
        In the study included all patients diagnosed with biopsy-proven BP in the Dermatology&#xD;
        Department of Attikon hospital between April 1, 2009 and December 31, 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biopsy proven bullous pemphigoid&#xD;
&#xD;
          -  severe bullous pemphigoid&#xD;
&#xD;
          -  recent manifestation of bullous pemphigoid (last four months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non bullous pemphigoid&#xD;
&#xD;
          -  presentation of bullous pemphigoid more than four months&#xD;
&#xD;
          -  treatment with DPP4is more than two years&#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>Vaia Lambadiari, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of internal medicine,University of Athens,Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Evangelia Papadavid, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of dermatology and venereology,University of Athens, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aikaterini Kountouri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of internal medicine,University of Athens,Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanouil Korakas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of internal medicine,University of Athens,Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sofia Theotokoglou</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of dermatology and venereology,University of Athens, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantinos Theodoropoulos</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of dermatology and venereology,University of Athens, Greece</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ignatios Ikonomidis, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd department of cardiology,University of Athens,Greece</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>&quot;Attikon&quot; University General Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Ignatios Ikonomidis</investigator_full_name>
    <investigator_title>Associate professsor of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemphigoid, Bullous</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04469582
org study id: BP-DPP4is
nct id: NCT04469582
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators conducted a prospective study which included all patients diagnosed with
      biopsy-proven BP in the Dermatology Department of Attikon hospital between April 1, 2009 and
      December 31, 2019. 113 consecutive patients with BP were identified. The investigators
      included the patients with type 2 diabetes and investigated the percentage of patients who
      were under treatment with DPP4-is. The specific DPP4-i prescribed was also documented.Medical
      information including patients' age, sex, other comorbidities and concomitant medications
      were also recorded. Furthermore, the investigators evaluated the effect of different types of
      treatment (topical steroids, systemic corticosteroids, immunosuppressive agents) on bullous
      pemphigoid.
Bullous pemphigoid (BP) is the most common chronic autoimmune skin disease which is
      characterized by the presentation of subepidermical blisters and mostly affects elderly
      patients . Recent studies have suggested that dipeptidyl peptidase-4 inhibitors (DPP-4is), an
      incretin-based drug for type 2 diabetes, as possible predisposing agents of BP . The
      objective of the study was to estimate the association between the use of DPP-4is and the
      development of BP in the setting of a tertiary university hospital and to raise awareness for
      everyday clinical practice, both among dermatologists as well as all physicians following
      patients with diabetes The study was designed as an observational prospective study.In the
      study included all patients who received a new diagnosis of BP and hospitalized in the
      Dermatology Department of our hospital between April 1, 2009 and December 31, 2019 Inclusion
      Criteria included a) biopsy proven bullous pemphigoid b) severe bullous pemphigoid c) recent
      manifestation of bullous pemphigoid (last four months).Exclusion Criteria included a) non
      bullous pemphigoid b) presentation of bullous pemphigoid more than four months c) treatment
      with DPP4is more than two years.

      Overall, 113 consecutive patients with the diagnosis of BP were enrolled in the study.The
      investigators reviewed the percentage of patients with type 2 diabetes among all patients
      with BP.The number of patients who were under treatment with DPP4-is and the specific type of
      DPP4-is prescribed were also examined.
observational model: Cohort
time perspective: Prospective
measure: Τhe correlation between the use of DPP-4is and the development of Bullous pemphigoid
time frame: baseline
description: The investigators assessed the percentage of patients who were under treatment with DPP4-is among patients with bullous pemphigoid
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vaia Lambadiari, MD,PhD
role: Principal Investigator
affiliation: 2nd department of internal medicine,University of Athens,Greece
last name: Evangelia Papadavid, MD,PhD
role: Principal Investigator
affiliation: 2nd department of dermatology and venereology,University of Athens, Greece
last name: Aikaterini Kountouri, MD
role: Principal Investigator
affiliation: 2nd department of internal medicine,University of Athens,Greece
last name: Emmanouil Korakas, MD
role: Principal Investigator
affiliation: 2nd department of internal medicine,University of Athens,Greece
last name: Sofia Theotokoglou
role: Principal Investigator
affiliation: 2nd department of dermatology and venereology,University of Athens, Greece
last name: Konstantinos Theodoropoulos
role: Principal Investigator
affiliation: 2nd department of dermatology and venereology,University of Athens, Greece
last name: Ignatios Ikonomidis, MD,PhD
role: Principal Investigator
affiliation: 2nd department of cardiology,University of Athens,Greece
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Ignatios Ikonomidis
investigator title: Associate professsor of Cardiology
mesh term: Pemphigoid, Bullous