Systemic SclerosisSCLERO-ESTHETNCT03271320
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- appearance scales
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2016to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: systemic sclerosis patients
Who may be able to join
- systemic sclerosis according to ACR-EULAR 2013
Who cannot join
- non French native
- aesthetic sequel from other conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Systemic Sclerosis
- Being tested
- appearance scales
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appearance scalesOther
appearance scales : AVS; ASWAP; DAS 59
| Study group | Role | What they receive |
|---|---|---|
| systemic sclerosis | patients with systemic sclerosis Receives: Other: appearance scales | |
| control | Healthy subjects Receives: Other: appearance scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual scale for aesthetic burden
Visual scale for aesthetic burden from 0 to 10
Measured: Baseline
Secondary outcomes (3)
Satisfaction with Appearance Scale (SWAP)
The SWAP measures body image dissatisfaction in persons with visible disfigurement
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start19 Dec 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271320
- Sponsor's protocol ID
- 2014_63
- Other IDs
- 2016-A00735-46
- Acronym
- SCLERO-ESTHET
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2017
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38910601
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03271320
- Acronym / sponsor ID
- SCLERO-ESTHET / 2014_63
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systemic sclerosis | – | Other: appearance scalespatients with systemic sclerosis |
| control | – | Other: appearance scalesHealthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- systemic sclerosis patients
Key inclusion criteria (1 listed)
- systemic sclerosis according to ACR-EULAR 2013
Key exclusion criteria (2 listed)
- non French native
- aesthetic sequel from other conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appearance scalesappearance scales : AVS; ASWAP; DAS 59 | Other | control, systemic sclerosis |
Primary outcome
Visual scale for aesthetic burden
Time frame: Baseline
Visual scale for aesthetic burden from 0 to 10
3 secondary outcomes
Satisfaction with Appearance Scale (SWAP)
Time frame: Baseline
Derriford Appearance Scale-59 (DAS)
Time frame: Baseline
Multidimensional Body self Relations Questionnaire (MBSRQ)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 38910601Farhat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual scale for aesthetic burden (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.