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

April 28, 2026 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Claude Huriez, CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

systemic sclerosis patients

Description

Inclusion Criteria:

  • systemic sclerosis according to ACR-EULAR 2013

Exclusion Criteria:

  • non French native
  • aesthetic sequel from other conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual scale for aesthetic burden
Time Frame: Baseline
Visual scale for aesthetic burden from 0 to 10
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Appearance Scale (SWAP)
Time Frame: Baseline
The SWAP measures body image dissatisfaction in persons with visible disfigurement
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_63
  • 2016-A00735-46 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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