Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

Recruiting now · Not applicable

Conditions studied: Systemic Scleroderma, Diffuse Cutaneous Scleroderma

In brief

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently a very imprecise, subjective method that varies amongst different doctors for the same patient is used to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). A previous plot study was conducted by the investigators to determine if spatial frequency domain imaging (SFDI), a method of light scattering, could be used to measure the collagen content in the skin of SSc patients. This non-painful, noninvasive method takes very little time and the investigators hypothesized that it would be more accurate than the "pinching" method. For that pilot study, patients with various stages of the disease were selected, and SFDI was used to image 6 areas. A forearm skin biopsy was taken for subsequent histopathology analyses of collagen content. The clinical mRSS was assessed at the time of SFDI measurement. Optical property imaging data was analyzed and statistically correlated and analyzed with immunohistochemistry (a method of identifying proteins) of the skin. Preliminary results demonstrated a strong correlation between mRSS and SFDI. Some of the imaging parameters of the SFDI were modified based on the initial results. Initial results demonstrated that the device can detect increases in skin thickness observed in SSc skin.

Key facts

Study ID: NCT07090226
Run by: Boston University
People needed: 65
Starts: 2025-11-06
Expected to finish: 2028-12-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Scleroderma (SSc) participants:
Diagnosed with SSc as defined by the American College of Rheumatology within the past 5 years AND fulfill criteria for diffuse cutaneous SSc according to LeRoy classification
Diagnosed with SSc as defined by the American College of Rheumatology within the past 3 years AND have documented evidence of RNA Polymerase III or anti-topoisomerase antibody positivity
Healthy controls must be free of SSc or other autoimmune disease and have no known skin pathology

You may not qualify if…

Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
Presence of other co-morbid illnesses with an estimated median life expectancy < 5 years.
Exclusion criteria for providing a skin biopsy sample during the study but are not exclusions for enrollment in the study.
Subject has known allergy to lidocaine or has had a reaction to local anesthetics in the past will not provide skin biopsy samples at any time during the study.
Subjects who, in the opinion of the investigator, are high-risk for small tissue calcification, or other conditions that may affect wound healing will not provide skin biopsy samples at any time during the study.
Subjects who are pregnant or lactating are excluded from providing a skin biopsy sample only while they are pregnant or lactating.

Where it is running

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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