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
• 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
• 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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

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