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NCT04804930 Clinical Trial

Trichoscopy and Systemic Scleroderma

Scleroderma, Systemic Clinical Trial

— TRICHLOSCLERO  

Official title:
Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04804930
Other study ID # 2018_87
Secondary ID 2020-A00566-33
Status Recruiting
Phase
First received
Last updated
Start date November 8, 2021
Est. completion date November 2023

Study information
Verified date March 2022
Source University Hospital, Lille
Contact Vincent Sobanski, MD
Phone 0320445962
Email vincent.sobanski@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hop Claude Huriez Chu Lille Lille

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

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