Longitudinal Spatial Frequency Domain Imaging Study

NCT05672992 | Active Not Recruiting

• 1 other identifier: H-43177
• Study Type: interventional
• Target: 78
• 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 imprecise and subjective methods that varies amongst different doctors for the same patient are available 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). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

Conditions

Systemic Scleroderma

Keywords

Spatial frequency domain imaging (SFDI); modified Rodnan skin score (mRSS); Skin biopsy; Skin fibrosis; Scleroderma skin patient reported outcome (SSPRO); Durometry; Ultrasound

Outcome Measures

Primary Outcomes (7)

• Baseline SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  baseline

• 6 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  6 months

• 12 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  12 months

• 18 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  18 months

• 24 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  24 months

• 30 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  30 months

• 36 months SFDI measurements of skin thickness

  SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms

  36 months

Secondary Outcomes (4)

• Serum fibrosis biomarkers, Chemokines that promote fibrosis

  baseline and every 12 months up to 36 months

• Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration

  baseline and every 12 months up to 36 months

• Serum fibrosis biomarkers, Matricellular proteins

  baseline and every 12 months up to 36 months

• histopathological assessments of skin collagen content

  baseline and every 12 months up to 36 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 the first study visit. Participants will be asked to complete the SSPRO questionnaire at the time of enrollment and every three months for the first 12 months and then every six months until the end of the study. At each study visit, a physician will measure the mRSS, which is a method of quantifying skin fibrosis; SFDI measurements, ultrasound, and durometry will then be done. Skin biopsies will be collected from the forearm of each subject annually. A small amount of blood will also be collected from subjects once per year to explore serum biomarkers of fibrosis.

Other: Spatial-frequency domain imaging (SFDI)

Healthy controls

ACTIVE COMPARATOR

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 the first study visit. At each study visit, SFDI measurements, ultrasound, and durometry will be done. Skin biopsies will be collected from the forearm of each subject annually. A small amount of blood will also be collected from subjects once per year to explore serum biomarkers of fibrosis.

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.

Healthy controls; Scleroderma Participants

Eligibility Criteria

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

You may qualify if:

• Participants must meet at least one of the following:
• Have SSc as defined by the American College of Rheumatology (SSc subjects only)
• Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only)
• Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results)

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.

Sponsors & Collaborators

• Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC): collaborator
• Boston University: lead
• Scleroderma Clinical Trials Consortium (SCTC): collaborator

Study Sites (1)

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

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

Study Design

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

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: February 10, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)