<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/NCT03271320</url>
  </required_header>
  <id_info>
    <org_study_id>2014_63</org_study_id>
    <secondary_id>2016-A00735-46</secondary_id>
    <nct_id>NCT03271320</nct_id>
  </id_info>
  <brief_title>Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis</brief_title>
  <acronym>SCLERO-ESTHET</acronym>
  <official_title>Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The primary objective is to assess the burden of aesthetic complication in systemic&#xD;
      sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the&#xD;
      appearance. Aesthetic burden will be assessed through several scales and compared to a&#xD;
      control group of health subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 19, 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual scale for aesthetic burden</measure>
    <time_frame>Baseline</time_frame>
    <description>Visual scale for aesthetic burden from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Appearance Scale (SWAP)</measure>
    <time_frame>Baseline</time_frame>
    <description>The SWAP measures body image dissatisfaction in persons with visible disfigurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Derriford Appearance Scale-59 (DAS)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Body self Relations Questionnaire (MBSRQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>The Multidimensional Body-Self Relations Questionnaire (MBSRQ) is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the body-image construct.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">170</enrollment>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>systemic sclerosis</arm_group_label>
    <description>patients with systemic sclerosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>appearance scales</intervention_name>
    <description>appearance scales : AVS; ASWAP; DAS 59</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>systemic sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        systemic sclerosis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  systemic sclerosis according to ACR-EULAR 2013&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non French native&#xD;
&#xD;
          -  aesthetic sequel from other conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2019</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>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271320
org study id: 2014_63
secondary id: 2016-A00735-46
nct id: NCT03271320
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to assess the burden of aesthetic complication in systemic
      sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the
      appearance. Aesthetic burden will be assessed through several scales and compared to a
      control group of health subjects.
observational model: Case-Control
time perspective: Prospective
measure: Visual scale for aesthetic burden
time frame: Baseline
description: Visual scale for aesthetic burden from 0 to 10
measure: Satisfaction with Appearance Scale (SWAP)
time frame: Baseline
description: The SWAP measures body image dissatisfaction in persons with visible disfigurement
measure: Derriford Appearance Scale-59 (DAS)
time frame: Baseline
description: The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance.
measure: Multidimensional Body self Relations Questionnaire (MBSRQ)
time frame: Baseline
description: The Multidimensional Body-Self Relations Questionnaire (MBSRQ) is a 69-item self-report inventory for the assessment of self-attitudinal aspects of the body-image construct.
arm group label: systemic sclerosis
description: patients with systemic sclerosis
arm group label: control
description: Healthy subjects
intervention type: Other
intervention name: appearance scales
description: appearance scales : AVS; ASWAP; DAS 59
arm group label: control
arm group label: systemic sclerosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Sclerosis
sharing ipd: No