Trichoscopy and Systemic Scleroderma
ConditionScleroderma, Systemic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
* 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
Signed informed consent
Being social insured
Disqualifiers
Patients aged less than 18 years old
patients under legal protection
patients deprived of their liberty
patients in emergency situations
Trial population
patients with systemic scleroderma
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
picture
Procedure/SurgeryWe 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: patients with systemic scleroderma1 intervention
Group B: healthy subject1 intervention
Trial outcomes
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
Time frame
BaselineSecondary outcomes
1
Correlation between visceral damage of systemic scleroderma and trichoscopic features
Frequency of visceral damage of systemic scleroderma: pulmonary hypertension, lung fibrosis, kidney failure.
Time frame
Baseline2
Correlation between global severity of systemic scleroderma and trichoscopic features
Correlation between EUSTAR score, Rodnan score, Medsger's score and trichoscopic features
Time frame
Baseline3
Correlation between autoimmune profile of sclerodermic patients and trichoscopic features
Correlation of antibodies, inflammatory profile of patients with trichoscopic features.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov