<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/NCT03272958</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC17.0066 ( PRURIPB)</org_study_id>
    <nct_id>NCT03272958</nct_id>
  </id_info>
  <brief_title>Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid</brief_title>
  <acronym>PRURIPB</acronym>
  <official_title>Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact&#xD;
      on quality of life have been little studied.&#xD;
&#xD;
      The objective of this study is to learn more about pruritus characteristics of patients with&#xD;
      bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus,&#xD;
      and then to better treat pruritus in this condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">October 3, 2018</completion_date>
  <primary_completion_date type="Actual">October 3, 2018</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>Clinical characteristics of pruritus in patients with bullous pemphigoid</measure>
    <time_frame>Day1 ( when diagnosis of bullous pemphigoid is made)</time_frame>
    <description>Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of pruritus on quality of life in patients with bullous pemphigoid</measure>
    <time_frame>Day 1 (when diagnosis of bullous pemphigoid is made )</time_frame>
    <description>Score 5D itch scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of pruritus on quality of life in patients with bullous pemphigoid</measure>
    <time_frame>Day1 (when diagnosis of bullous pemphigoid is made )</time_frame>
    <description>score ItchyQol (Itchy Quality of Life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of pruritus on quality of life in patients with bullous pemphigoid</measure>
    <time_frame>Day 1 (when diagnosis of bullous pemphigoid is made )</time_frame>
    <description>score ABQOL</description>
  </secondary_outcome>
  <enrollment type="Actual">63</enrollment>
  <condition>Bullous Pemphigoid</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a new diagnosis of bullous pemphigoid&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult&#xD;
&#xD;
          -  pruriginous bullous pemphigoid lately diagnosed.&#xD;
&#xD;
          -  Without PB treatment&#xD;
&#xD;
          -  MMS (Mini Mental State Examination) ≥ 21&#xD;
&#xD;
          -  In hospitalization or consultation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CH Argenteuil</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP, Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33404</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP, Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Le Havre</name>
      <address>
        <city>Le Havre</city>
        <zip>76083</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HP-HM</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Niort</name>
      <address>
        <city>Niort</city>
        <zip>79021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP, Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75006</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP, Hôpital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pruritus</keyword>
  <keyword>Bullous pemphigoid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
    <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/NCT03272958
org study id: 29BRC17.0066 ( PRURIPB)
nct id: NCT03272958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact
      on quality of life have been little studied.

      The objective of this study is to learn more about pruritus characteristics of patients with
      bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus,
      and then to better treat pruritus in this condition.
observational model: Cohort
time perspective: Prospective
measure: Clinical characteristics of pruritus in patients with bullous pemphigoid
time frame: Day1 ( when diagnosis of bullous pemphigoid is made)
description: Answers and scores in questionnaire about clinical characteristics of pruritus Demographics characteristics of patients Characteristics of the bullous pemphigoid
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
time frame: Day 1 (when diagnosis of bullous pemphigoid is made )
description: Score 5D itch scale
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
time frame: Day1 (when diagnosis of bullous pemphigoid is made )
description: score ItchyQol (Itchy Quality of Life)
measure: Impact of pruritus on quality of life in patients with bullous pemphigoid
time frame: Day 1 (when diagnosis of bullous pemphigoid is made )
description: score ABQOL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
responsible party type: Sponsor
mesh term: Pruritus
mesh term: Pemphigoid, Bullous