Trichoscopy and Systemic Scleroderma

NCT04804930 | Recruiting

• 2 other identifiers: 2018_872020-A00566-33
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Scleroderma, Systemic

Keywords

Trichoscopy; Dermoscopy; Systemic Scleroderma; Scalp

Outcome Measures

Primary Outcomes (1)

• Frequency of elementary lesions observed by trichoscopic assessment of the scalp

  Comparison of the frequencies of elementary lesions visualized in patients with systemic scleroderma and healthy subjects

  Baseline

Secondary Outcomes (3)

• Correlation between visceral damage of systemic scleroderma and trichoscopic features

  Baseline

• Correlation between global severity of systemic scleroderma and trichoscopic features

  Baseline

• Correlation between autoimmune profile of sclerodermic patients and trichoscopic features

  Baseline

Study Arms (2)

patients with systemic scleroderma

Procedure: picture

healthy subject

healthy subject without systemic scleroderma or known hair or scalp disease

Procedure: picture

Interventions

picture PROCEDURE

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

Also known as: Non-invasive trichoscopy: dermoscopic assessment of the scalp (picture)

healthy subject; patients with systemic scleroderma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with systemic scleroderma

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Vincent Sobanski, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Sobanski, MD

CONTACT

0320445962; vincent.sobanski@chru-lille.fr

Study Design

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

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: November 8, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)