NCT03271320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

August 31, 2017

Last Update Submit

April 28, 2026

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Visual scale for aesthetic burden

    Visual scale for aesthetic burden from 0 to 10

    Baseline

Secondary Outcomes (3)

  • Satisfaction with Appearance Scale (SWAP)

    Baseline

  • Derriford Appearance Scale-59 (DAS)

    Baseline

  • Multidimensional Body self Relations Questionnaire (MBSRQ)

    Baseline

Study Arms (2)

systemic sclerosis

patients with systemic sclerosis

Other: appearance scales

control

Healthy subjects

Other: appearance scales

Interventions

appearance scalesOTHER

appearance scales : AVS; ASWAP; DAS 59

controlsystemic sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

systemic sclerosis patients

You may qualify if:

  • systemic sclerosis according to ACR-EULAR 2013

You may not qualify if:

  • non French native
  • aesthetic sequel from other conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHRU

Lille, France

Location

Related Publications (1)

  • Farhat MM, Guerreschi P, Morell-Dubois S, Deken V, Labreuche J, Sanges S, Sobanski V, Hachulla E, Cottencin O, Launay D. Perception of aesthetic impairment in patients with systemic sclerosis determined using a semi-quantitative scale and its association with disease characteristics. J Scleroderma Relat Disord. 2024 Jun;9(2):124-133. doi: 10.1177/23971983241231620. Epub 2024 Feb 27.

    PMID: 38910601RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

December 19, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)