<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/NCT03297580</url>
  </required_header>
  <id_info>
    <org_study_id>SCLERODERMIE</org_study_id>
    <nct_id>NCT03297580</nct_id>
  </id_info>
  <brief_title>Itch and Clinacal Caracteristics in Systemic Sclerosis</brief_title>
  <acronym>SCLERODERMIE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity.&#xD;
      Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators&#xD;
      knowledge, no study yet has examined the clinical features of itch neither had used a&#xD;
      specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were&#xD;
      to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in&#xD;
      those patients.&#xD;
&#xD;
      In this descriptive study, patients followed for SSc in the departments of dermatology,&#xD;
      rheumatology, internal medicine and pulmonology at the University Hospital of Brest were&#xD;
      included. Participants received a questionnaire including questions about the clinical&#xD;
      features of pruritus and 2 scores (5-D itch scale, ItchyQol).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">March 31, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</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>Pruritus</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>Pruritus: yes/no</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the systemic sclerosis</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>Duration of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brest questionnaire</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>questions about the chronology, location, intensity, disruption of daily activities, characteristics of scratching and other associated sensations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-D itch scale</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ItchyQol scale</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>questionnaire about quality of life linked to pruritus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the systemic sclerosis</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>treatments,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the systemic sclerosis</measure>
    <time_frame>Day 1 (questionnaire sent to patient)</time_frame>
    <description>topography of skin involvement (limited or diffuse systemic sclerosis)</description>
  </secondary_outcome>
  <enrollment type="Actual">61</enrollment>
  <condition>Pruritus</condition>
  <condition>Systemic Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with a systemic sclerosis followed in the University Hospital of Brest&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged more than 18 years&#xD;
&#xD;
          -  followed for systemic sclerosis since 2000, in the departments of dermatology,&#xD;
             rheumatology, internal médicine or pneumology at the University Hospital of Brest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lower than 18 years&#xD;
&#xD;
          -  refusal to participate&#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>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Pruritus</mesh_term>
    <mesh_term>Sclerosis</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/NCT03297580
org study id: SCLERODERMIE
nct id: NCT03297580
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity.
      Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators
      knowledge, no study yet has examined the clinical features of itch neither had used a
      specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were
      to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in
      those patients.

      In this descriptive study, patients followed for SSc in the departments of dermatology,
      rheumatology, internal medicine and pulmonology at the University Hospital of Brest were
      included. Participants received a questionnaire including questions about the clinical
      features of pruritus and 2 scores (5-D itch scale, ItchyQol).
observational model: Cohort
time perspective: Prospective
measure: Pruritus
time frame: Day 1 (questionnaire sent to patient)
description: Pruritus: yes/no
measure: Characteristics of the systemic sclerosis
time frame: Day 1 (questionnaire sent to patient)
description: Duration of the disease
measure: Brest questionnaire
time frame: Day 1 (questionnaire sent to patient)
description: questions about the chronology, location, intensity, disruption of daily activities, characteristics of scratching and other associated sensations
measure: 5-D itch scale
time frame: Day 1 (questionnaire sent to patient)
description: Validated questionnaire about severity of pruritus using five items (duration, intensity, evolution, impact on daily activities, localisation)
measure: ItchyQol scale
time frame: Day 1 (questionnaire sent to patient)
description: questionnaire about quality of life linked to pruritus
measure: Characteristics of the systemic sclerosis
time frame: Day 1 (questionnaire sent to patient)
description: treatments,
measure: Characteristics of the systemic sclerosis
time frame: Day 1 (questionnaire sent to patient)
description: topography of skin involvement (limited or diffuse systemic sclerosis)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Pruritus
mesh term: Sclerosis