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NCT Number: NCT05672992

Longitudinal Spatial Frequency Domain Imaging Study

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.

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Key information

Conditions

Systemic Scleroderma Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shapiro Outpatient Rheumatology Clinic at Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

The overall objective of this study is to determine if a light emitting diode (LED) -based SFDI instrument can be used to detect changes in skin thickness over time in SSc patients.

Number of subjects:

60 patients with scleroderma and 32 control subjects without scleroderma

Study procedures:

All subjects will have 6 areas of the body, right and left fingers, hands, and forearms, measured with an LED-based SFDI instrument every 3 months for the first 12 months and then every 6 months through 36 months. The right and left upper arms of subjects may be measured with the SFDI instrument if subjects are able to comfortably extend their arms.

All subjects will have the option to have blood collected for serum at baseline, 12 months, 24 months, and 36 months to investigate serum biomarkers of fibrosis.

An optional skin biopsy will be collected from all subjects at baseline, 12 months, 24 months, and 36 months to evaluate histopathological skin changes. Skin biopsies will not be collected from pregnant or lactating subjects, from subjects with a history of an allergic reaction to a local anesthetic, or from subjects who are deemed by the study doctor to be at high risk of small tissue calcification.

Scleroderma subjects will be asked to complete the SSPRO questionnaire at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

Scleroderma subjects will have a mRSS performed at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

All subjects will have durometry and ultrasound performed on the right and left forearms at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

Secondary Objectives:

  • Assess how SFDI measurements correlate with other clinical measurements of skin thickness such as durometry, ultrasound, and mRSS
  • Assess how SFDI measurements correlate with clinical biochemical and histopathological assessments of skin changes in SSc.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

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.

Treatment and study plan

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.

Primary outcomes

  1. Baseline SFDI measurements of skin thickness

    Time frame: baseline

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

  2. 6 months SFDI measurements of skin thickness

    Time frame: 6 months

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

  3. 12 months SFDI measurements of skin thickness

    Time frame: 12 months

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

  4. 18 months SFDI measurements of skin thickness

    Time frame: 18 months

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

  5. 24 months SFDI measurements of skin thickness

    Time frame: 24 months

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

  6. 30 months SFDI measurements of skin thickness

    Time frame: 30 months

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

  7. 36 months SFDI measurements of skin thickness

    Time frame: 36 months

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

Secondary outcomes

  1. Serum fibrosis biomarkers, Chemokines that promote fibrosis

    Time frame: baseline and every 12 months up to 36 months

    Assessed from serum

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

    Time frame: baseline and every 12 months up to 36 months

    Assessed from serum

  3. Serum fibrosis biomarkers, Matricellular proteins

    Time frame: baseline and every 12 months up to 36 months

    Assessed from serum

  4. histopathological assessments of skin collagen content

    Time frame: baseline and every 12 months up to 36 months

    Assessed from skin biopsy samples

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

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

Registry information

Official study title

Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma

Acronym: SFDI

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 5, 2023
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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