NCT04532151

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

July 29, 2020

Last Update Submit

August 10, 2023

Conditions

Systemic SclerosisEarly Systemic Sclerosis Without Clinical Scleroderma and Onset < 2 Years

Keywords

Systemic sclerosisSclerodermaOptical coherence tomography (OCT)

Outcome Measures

Primary Outcomes (2)

  • Optic density of the papillo-reticular dermis on the dorsal surface of a finger

    The optic density of the papillo-reticular dermis, 300 μm deep, on the dorsal surface of a finger will be measured in all three groups using optical coherence tomography (OCT)

    This parameter will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0)

  • Optic density of the papillo-reticular dermis on the dorsal surface of a finger

    Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).

Secondary Outcomes (8)

  • Optic density of the papillo-reticular dermis at the outer and inner side of the forearm

    These parameters will be evaluated during a hospital consultation. The test lasts 30 minutes. For all three groups, the measurements will be taken at the time of the inclusion visit (V0).

  • Optic density of the papillo-reticular dermis at the outer and inner side of the forearm

    Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).

  • Modified Rodnan skin score (mRSS)

    The assessment will be applied only to patients in group 1 (Early SSc group) and group 2 (Established SSc group) at the inclusion visit (V0).

  • Modified Rodnan skin score (mRSS)

    Only the patient of group 1 (Early SSc group) will be evaluated again during the visit of Month 24 (V M24).

  • The thickness of the hypodermis, obtained by HD ultrasound.

    Day 0

  • +3 more secondary outcomes

Study Arms (3)

Early SSc group

OTHER

Patients with SSc according to the criteria ACR / EULAR 2013, without scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements. Patients will be reassessed at M24. The participation of each subject will be 24 months, with two visits of one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form.

Diagnostic Test: Non-invasive skin imaging assessment

Established SSc group

OTHER

Patients with SSc according to criteria ACR / EULAR 2013 with scleroderma Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The mRSS will be evaluated by an experienced clinician, blinded from imaging measurements. The participation of each subject will be one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form.

Diagnostic Test: Non-invasive skin imaging assessment

Control group:

OTHER

Patient without systemic sclerosis Normal routine clinical examinations and routine biology tests will be performed. For non-invasive imaging specific to the study, various parameters will be measured on the finger and forearm by LC-OCT, LC-OCT-Doppler, HD ultrasound as well as fluid silicone molding in a dimly lit room. The participation of each subject will be one hour. The clinical data corresponding to the current practice will be collected in a study specific case report form.

Diagnostic Test: Non-invasive skin imaging assessment

Interventions

Non-invasive skin imaging assessmentDIAGNOSTIC_TEST

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.

Control group:Early SSc groupEstablished SSc group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major subject (age ≥ 18 years)
  • Male or female subject
  • Subject affiliated to a social health insurance scheme
  • Subject having signed an informed consent
  • Subject having been informed of the results of the prior medical examination
  • Group 1 "Early SSc group": Patients with SSc according to ACR / EULAR criteria (2013) early onset \<2 years and without clinical cutaneous sclerosis
  • Group 2 "Established SSc group": Patients with SSc according to ACR / EULAR criteria (2013) with cutaneous sclerosis
  • Group 3 "Control group": Hospitalized patients in the Rheumatology Department of the University Hospitals of Strasbourg, excluding connective tissue disease

You may not qualify if:

  • Subject having undergone a physical treatment (radiotherapy, surgical intervention ...) on the cutaneous sites studied
  • Subjects who received general corticosteroid therapy in the last 3 months
  • Subjects being treated with topical corticosteroids on the different cutaneous sites studied
  • Impossibility to give clear information of subject (subject in emergency situation, subject with difficulties of understanding ...)
  • Subject under the protection of justice, guardianship or curatorship
  • Pregnancy (on declaration of the patient)
  • \- Group 1 "Early SSc group": Patients with SSc and having a clinical cutaneous sclerosis
  • \- Group 2 "Established SSc group": Patients with criteria for another systemic autoimmune disease
  • \- Group 3 "Control group":
  • Subjects with scleroderma,
  • Subjects with Raynaud's phenomenon
  • Subjects with other sclerosing disease (morphea, Shulman,…)
  • Diabetic subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Emmanuel Chatelus, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is an open-label study. The mRSS will be performed by an independent clinician
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 31, 2020

Study Start

February 2, 2021

Primary Completion

May 26, 2023

Study Completion

July 19, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

FR(1)