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Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis (SCLERO-ESTHET)

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ClinicalTrials.gov Identifier: NCT03271320
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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.

Condition or disease Intervention/treatment
Systemic Sclerosis Other: appearance scales

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
Actual Study Start Date : December 19, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Group/Cohort Intervention/treatment
systemic sclerosis
patients with systemic sclerosis
Other: appearance scales
appearance scales : AVS; ASWAP; DAS 59

control
Healthy subjects
Other: appearance scales
appearance scales : AVS; ASWAP; DAS 59




Primary Outcome Measures :
  1. Visual scale for aesthetic burden [ Time Frame: Baseline ]
    Visual scale for aesthetic burden from 0 to 10


Secondary Outcome Measures :
  1. Satisfaction with Appearance Scale (SWAP) [ Time Frame: Baseline ]
    The SWAP measures body image dissatisfaction in persons with visible disfigurement

  2. Derriford Appearance Scale-59 (DAS) [ Time Frame: Baseline ]
    The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance.

  3. Multidimensional Body self Relations Questionnaire (MBSRQ) [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
systemic sclerosis patients
Criteria

Inclusion Criteria:

  • systemic sclerosis according to ACR-EULAR 2013

Exclusion Criteria:

  • non French native
  • aesthetic sequel from other conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271320


Contacts
Contact: David Launay, MD, PHD +33320444433 david.launay@chru-lille.fr

Locations
France
Hôpital Claude Huriez, CHRU Recruiting
Lille, France
Principal Investigator: David Launay, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03271320     History of Changes
Other Study ID Numbers: 2014_63
2016-A00735-46 ( Other Identifier: ID-RCB number )
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases