Systemic SclerosisSkin-SSCNCT05273138
Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
An observational study of Systemic Sclerosis, run by University Hospital, Lille at 1 site in France.
Trial summary
The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Blood sampling and skin biopsy
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 from the University Hospital of Lille
Who may be able to join
- Man or woman over 18 years of age
- With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent
- Being insured
Who cannot join
- Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria
- Immunosuppressive treatment within 12 months
- Dosage of current corticosteroid therapy ≥10mg/d
- Protected minors or adults
- Pregnant or breastfeeding women
- Deprived of their liberty
- Persons in emergency situations
- Persons who have refused or are unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962, DRS@chru-lille.fr
About this study
The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc
- Conditions
- Systemic Sclerosis
- Being tested
- Blood sampling and skin biopsy
- Keywords
- Systemic sclerosis, Fibrosis, fibroblasts., Fibroblasts., Immune system., B lymphocytes.
- Medical subject headings
- Scleroderma, Systemic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling and skin biopsyOther
Blood sampling and skin biopsy
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis patients | Patients fulfilling the ACR/EULAR criteria for systemic sclerosis Receives: Other: Blood sampling and skin biopsy | |
| Healthy subjects | Not described Receives: Other: Blood sampling and skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single cell RNAseq transcriptomic analysis of skin
Measured: At inclusion
Secondary outcomes (1)
Single cell RNAseq transcriptomic analysis of the whole blood
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start8 Jun 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273138
- Sponsor's protocol ID
- 2021_0611
- Other IDs
- 2021-A03137-34
- Acronym
- Skin-SSC
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2022
- Last updated
- 26 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05273138
- Acronym / sponsor ID
- Skin-SSC / 2021_0611
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, Fibrosis, fibroblasts., Fibroblasts., Immune system., B lymphocytes.
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Mar 2022 (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.
The pathophysiology of systemic sclerosis (SSc) is still poorly understood and there are no effective treatments for this disease. SSc is a heterogeneous disease with varying severity. The heterogeneity of fibroblast profiles, observed in other fibrosing pathologies, has never been thoroughly explored in the skin of SSc patients. The immune system, and in particular B lymphocytes, plays a central role in the pathophysiology of SSc. The interactions between B lymphocytes and the cells responsible for excess collagen production, i.e. fibroblasts, are not fully elucidated The main objective is to analyze the heterogeneity of fibroblasts and infiltrating immune cells as well as their molecular signature in the skin of patients with SSc
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis patients | – | Other: Blood sampling and skin biopsyPatients fulfilling the ACR/EULAR criteria for systemic sclerosis |
| Healthy subjects | – | Other: Blood sampling and skin biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the University Hospital of Lille
Key inclusion criteria (3 listed)
- Man or woman over 18 years of age
- With a systemic sclerosis meeting the ACR-EULAR 2013 criteria Having signed an informed consent
- Being insured
Key exclusion criteria (8 listed)
- Syndrome of overlap with another connective tissue disease according to the international diagnostic criteria
- Immunosuppressive treatment within 12 months
- Dosage of current corticosteroid therapy ≥10mg/d
- Protected minors or adults
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling and skin biopsyBlood sampling and skin biopsy | Other | Healthy subjects, Systemic sclerosis patients |
Primary outcome
Single cell RNAseq transcriptomic analysis of skin
Time frame: At inclusion
1 secondary outcome
Single cell RNAseq transcriptomic analysis of the whole blood
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
David Launay, MD,PhD principal investigator
University Hospital, Lille
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 Systemic Sclerosis, run by University Hospital, Lille 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Launay, MD,PhD (0320445962, david.launay@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single cell RNAseq transcriptomic analysis of skin (time frame: At inclusion). 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 26 Dec 2025.