Validation of Raman Spectroscopy Usefulness in Systemic SclerosisRAMSESNCT04996082
Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
An observational study of Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2021to 21 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with or without systemic sclerosis, according to ACR criteria, older than 18-years-old
Who may be able to join
- patients with SSc, according to ACR criteria
- older than 18-years-old exclusion criteria :
- younger than 18-years-old
- patient protected by law
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Systemic sclerosis, Raman spectroscopy
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis group | Patients with systemic sclerosis | |
| No Systemic sclerosis group | Patients without systemic sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raman spectroscopy
Measured: at 6 months
Raman spectroscopy
Measured: at 12 months
Raman spectroscopy
Measured: at 24 months
Raman spectroscopy
Measured: at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start8 Apr 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of Raman Spectroscopy Usefulness in Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996082
- Sponsor's protocol ID
- PO21044
- Acronym
- RAMSES
- Status last verified
- Dec 2025
- First submitted
- 3 Aug 2021
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04996082
- Acronym / sponsor ID
- RAMSES / PO21044
- Keywords
- Systemic sclerosis, Raman spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis group | – | –Patients with systemic sclerosis |
| No Systemic sclerosis group | – | –Patients without systemic sclerosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without systemic sclerosis, according to ACR criteria, older than 18-years-old
Key inclusion criteria (4 listed)
- patients with SSc, according to ACR criteria
- older than 18-years-old exclusion criteria :
- younger than 18-years-old
- patient protected by law
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Raman spectroscopy
Time frame: at 6 months
Raman spectroscopy
Time frame: at 12 months
Raman spectroscopy
Time frame: at 24 months
Raman spectroscopy
Time frame: at 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raman spectroscopy (time frame: at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.