NCT04996082

Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc. An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics. Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

Detailed description

Raman spectroscopy will be performed on patients with SSc, according to the ACR criteria, and control patients without SSc, on 3 different areas of the skin. Patients with SSc and controls will be matched by gender and age. These measures will be performed at 6 months, 12 months, 24 months and 36 months.

Conditions

• Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis

Timeline

• Start date: 2021-04-08
• Primary completion: 2023-07-21
• Completion: 2023-07-21
• First posted: 2021-08-09
• Last updated: 2025-12-19

Locations

1 site across 1 country: France