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Optical Coherence Tomography Imaging in Systemic Sclerosis

NCT04532151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-14

No results posted yet for this study

Summary

Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis.

Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis.

The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.

Conditions

  • Systemic Sclerosis
  • Early Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years

Interventions

DIAGNOSTIC_TEST

Non-invasive skin imaging assessment

Intervention Description : (Limit: 1000 characters) Do not repeat information already included in arm/group descriptions. Specify details not covered in associated Arm One session of Non-invasive skin imaging assessment contained: * an examination on LC-OCT * an examination on LC-OCT-doppler * a fluid silicone molding * an examination on HD ultrasound The measurements will be applied on 3 skin sites: the dorsal surface of the finger, the inner face and the outer surface of the forearm. The imaging assessment lasts 30 minutes in a dimly lit room where the humidity and temperature are stable.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Emmanuel Chatelus, MD · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2023-05-26
Completion
2023-07-19

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532151 on ClinicalTrials.gov