Recruiting

SFDI

Sponsor:

Boston University

Code:

NCT07090226

Conditions

Systemic Scleroderma

Diffuse Cutaneous Scleroderma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Spatial-frequency domain imaging (SFDI)

Study Details

Brief summary:

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.

Conditions

Systemic Scleroderma

Diffuse Cutaneous Scleroderma

Study ID

NCT07090226

Start date

Nov 6, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Spatial-frequency domain imaging (SFDI)

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Benjamin Chamis

617-358-6792bchamis@bu.edu

Britte Beaudette-Zlatanova, PhD

617-358-6171britte@bu.edu

Locations

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

More Information

Sponsor

Boston University

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Spatial frequency domain imaging (SFDI)
  • modified Rodnan skin score (mRSS)
  • Skin biopsy
  • Skin fibrosis
  • Scleroderma skin patient reported outcome (SSPRO)
  • Durometry
  • Ultrasound
  • Diffuse cutaneous scleroderma (dcSSc)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-07-23.