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NCT Number: NCT05273138

Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis

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

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood sampling and skin biopsy

Other

Blood sampling and skin biopsy

Primary outcomes

  1. Single cell RNAseq transcriptomic analysis of skin

    Time frame: At inclusion

Secondary outcomes

  1. Single cell RNAseq transcriptomic analysis of the whole blood

    Time frame: At inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

David Launay, MD,PhD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: Skin-SSC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2022
Registry last updated
Dec 26, 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.

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