Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT07090226
Status
Recruiting
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Conditions

  • Diffuse Cutaneous Scleroderma
  • Systemic Scleroderma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Spatial-frequency domain imaging (SFDI) — OTHER
    SFDI is a method using near-infrared (NIR) light to generate wide field images (\>10 x 10 cm) of tissue optical properties (absorption and scattering coefficients) at sub-surface depths of 1-10 mm. With SFDI the tissue surface (skin) is illuminated by a rapid sequence of sinusoidal light patterns of varying spatial frequency and at different optical wavelengths. Collected camera images are then processed to yield maps of sub-surface optical properties.

Study Details

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 Dates

Start date
Nov 6, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Scleroderma Participants
    Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone and will have measurements taken with a colorimeter on the right and left forearms, hands, and fingers to quantify skin tone. At each study visit, a physician will measure the mRSS and take SFDI measurements. Ultrasound and durometry will then be done. Optional skin biopsies will be collected from the forearm at baseline and 12 months.
  • Active Comparator: Control
    Participants in this arm will be asked to complete SFDI and colorimeter measurements.

Primary Outcome Measure

Spatial-frequency domain imaging (SFDI) measurements of skin thickness [ Time Frame: Baseline, 3 months, 6 months.12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shapiro Outpatient Rheumatology Clinic at Boston Medical CenterBostonMassachusetts02118
Britte Beaudette-Zlatanova, PhD

Find similar trials in Boston, MA

By research site
Shapiro Outpatient Rheumatology Clinic at Boston Medical Center· Boston, MA

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