Skip to main content
OpenTrials
Completed

NCT Number: NCT04996082

Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Damien JOLLY

Reims, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with SSc, according to ACR criteria
  • older than 18-years-old exclusion criteria :
  • younger than 18-years-old
  • patient protected by law

Treatment and study plan

Primary outcomes

  1. Raman spectroscopy

    Time frame: at 6 months

  2. Raman spectroscopy

    Time frame: at 12 months

  3. Raman spectroscopy

    Time frame: at 24 months

  4. Raman spectroscopy

    Time frame: at 36 months

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: RAMSES

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.