Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

NCT07090226 | Recruiting DMC

• 2 other identifiers: H-46158R01AR085317-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

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)

Outcome Measures

Primary Outcomes (2)

• Spatial-frequency domain imaging (SFDI) measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms. Total SFDI score is defined as the sum of the individual SFDI measurements.

  Baseline, 3 months, 6 months.12 months

• Modified Rodnan skin score (mRSS) measurements of skin thickness

  One of two methods will be used to assess the mRSS: 1) gently pinch the skin using the index finger and thumb, or 2) press the skin between two thumbs to form a fold of skin. to score the 17 body areas on a scale. of 0-3 (0 is normal, 1 is mild thickness, 2 is moderate thickness, and 3 is severe thickness). The range of possible scores is 0 to 51 and a higher total mRSS score generally indicates more severe skin involvement and a worse prognosis in SSc.

  Baseline, 3 months, 6 months.12 months

Secondary Outcomes (7)

• Ultrasound measurements of the forearms

  Baseline, 3 months, 6 months.12 months

• Ultrasound measurements of the hands

  Baseline, 3 months, 6 months.12 months

• Ultrasound measurements of the fingers

  Baseline, 3 months, 6 months.12 months

• Durometry measurements of the forearm

  Baseline, 3 months, 6 months.12 months

• Durometry measurements of the hands

  Baseline, 3 months, 6 months.12 months

Study Arms (2)

Scleroderma Participants

EXPERIMENTAL

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.

Other: Spatial-frequency domain imaging (SFDI)

Control

ACTIVE COMPARATOR

Participants in this arm will be asked to complete SFDI and colorimeter measurements.

Other: Spatial-frequency domain imaging (SFDI)

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.

Control; Scleroderma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scleroderma (SSc) participants must have been diagnosed with SSc as defined by the American College of Rheumatology within the past 2-5 years AND fulfill criteria for diffuse cutaneous SSc according to LeRoy classification
• 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.
• 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.

Sponsors & Collaborators

• Boston University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Andreea Bujor, MD, PhD

  BU Chobanian & Advesian School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Chamis

CONTACT

617-358-6792; bchamis@bu.edu

Britte Beaudette-Zlatanova, PhD

CONTACT

617-358-6171; britte@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 60 patients with scleroderma and 5 control participants without scleroderma.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)