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Recruiting NCT04804930

Trichoscopy and Systemic Scleroderma

Observational Scleroderma, Systemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: picture.
Who it may be relevant to
Registry conditions: Scleroderma, Systemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma

Overview

* 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

Interventions

  • 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

Primary outcome measures

  • Frequency of elementary lesions observed by trichoscopic assessment of the scalp [Time frame: Baseline]
Secondary outcome measures (3)
  • Correlation between visceral damage of systemic scleroderma and trichoscopic features [Time frame: Baseline]
  • Correlation between global severity of systemic scleroderma and trichoscopic features [Time frame: Baseline]
  • Correlation between autoimmune profile of sclerodermic patients and trichoscopic features [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hop Claude Huriez Chu Lille — Lille

Identifiers

NCT: NCT04804930 · 2018_87 · 2020-A00566-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗