Trichoscopy and Systemic Scleroderma (TRICHLOSCLERO)

April 21, 2026 updated by: University Hospital, Lille

Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma

  • Few data are available on scalp involvement in systemic scleroderma.
  • Few data are available on the association between scalp abnormalities and features of systemic scleroderma
  • Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
  • There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma

The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Recruiting
        • Hop Claude Huriez Chu Lille
        • Principal Investigator:
          • Vincent Sobansky, MD
        • Contact:
          • Phone Number: 0320445962

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with systemic scleroderma

Description

Inclusion Criteria:

  • Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
  • Signed informed consent
  • Being social insured

Exclusion Criteria:

  • Patients aged less than 18 years old
  • patients under legal protection
  • patients deprived of their liberty
  • patients in emergency situations
  • patients who refused or unable to give informed consent
  • For the control group: sclap inflammatory disease active the day of the examination

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
patients with systemic scleroderma
Procedure: picture
We will perform a non-invasive assessment of the scalp with a dermoscope by taking two standardized pictures on the frontal area and the occipital area in order to a blinded analysis of trichoscopic patterns
Other Names:
  • Non-invasive trichoscopy: dermoscopic assessment of the scalp (picture)
healthy subject
healthy subject without systemic scleroderma or known hair or scalp disease
Procedure: picture
We will perform a non-invasive assessment of the scalp with a dermoscope by taking two standardized pictures on the frontal area and the occipital area in order to a blinded analysis of trichoscopic patterns
Other Names:
  • Non-invasive trichoscopy: dermoscopic assessment of the scalp (picture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of elementary lesions observed by trichoscopic assessment of the scalp
Time Frame: Baseline
Comparison of the frequencies of elementary lesions visualized in patients with systemic scleroderma and healthy subjects
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between visceral damage of systemic scleroderma and trichoscopic features
Time Frame: Baseline
Frequency of visceral damage of systemic scleroderma: pulmonary hypertension, lung fibrosis, kidney failure.
Baseline
Correlation between global severity of systemic scleroderma and trichoscopic features
Time Frame: Baseline
Correlation between EUSTAR score, Rodnan score, Medsger's score and trichoscopic features
Baseline
Correlation between autoimmune profile of sclerodermic patients and trichoscopic features
Time Frame: Baseline
Correlation of antibodies, inflammatory profile of patients with trichoscopic features.
Baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Vincent Sobanski, MD, University Hospital, Lille

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)

November 8, 2021

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_87
  • 2020-A00566-33 (Other Identifier: ID-RCB number,ANSM)

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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