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NCT03271320 Clinical Trial

Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SCLERO-ESTHET  

Official title:
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03271320
Other study ID # 2014_63
Secondary ID 2016-A00735-46
Status Completed
Phase
First received
Last updated
Start date December 19, 2016
Est. completion date March 2018

Study information
Verified date June 2019
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- systemic sclerosis according to ACR-EULAR 2013

Exclusion Criteria:

- non French native

- aesthetic sequel from other conditions

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• appearance scales
appearance scales : AVS; ASWAP; DAS 59

Locations
Country Name City State
France Hôpital Claude Huriez, CHRU Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual scale for aesthetic burden Visual scale for aesthetic burden from 0 to 10 Baseline
Secondary Satisfaction with Appearance Scale (SWAP) The SWAP measures body image dissatisfaction in persons with visible disfigurement Baseline
Secondary Derriford Appearance Scale-59 (DAS) The Derriford Appearance Scales measure the spectrum of psychological distress and dysfunction that is characteristic of disfigurements, deformities and aesthetic problems of appearance. Baseline
Secondary Multidimensional Body self Relations Questionnaire (MBSRQ) 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. Baseline
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