Systemic SclerodermaSFDINCT07090226
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
A study testing Spatial-frequency domain imaging (SFDI) in people with Systemic Scleroderma and Diffuse Cutaneous Scleroderma, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Scleroderma, Diffuse Cutaneous Scleroderma
- What is being tested?
- Spatial-frequency domain imaging (SFDI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
Boston, Massachusetts, 02118
Britte Beaudette-Zlatanova, PhD
About this study
Official title: Assessing Spatial Frequency Domain Imaging as an Objective Quantification of Longitudinal Skin Changes in Scleroderma
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.
Read the detailed description
- The primary objective of this study is to validate spatial-frequency domain imaging (SFDI) and related optical techniques as robust, sensitive, and objective methods for quantifying skin involvement in systemic sclerosis. The study aims to use SFDI/SLIM to examine longitudinal skin changes in early diffuse cutaneous SSc patients and the correlation with change in modified Rodnan Skin Score (mRSS).
- Secondary objectives include assessing correlations between SFDI measurements of skin in SSc subjects and other clinical outcomes such as durometry, ultrasound, histopathological changes in the skin, or scleroderma patient reported outcomes (PROs).
In the current study longitudinal measurements in SSc patients will be taken to examine: the sensitivity and accuracy of SFDI to detect changes in skin thickness over time in response to therapy or from disease progression, the correlation between SFDI measurements and mRSS, and the expression of proteins including PDGFRβ in skin biopsy tissue.
In this study SFDI and other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness) will be compared. SFDI information will also be compared with capillaroscopy (that 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 as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.
- Being tested
- Spatial-frequency domain imaging (SFDI)
- 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)
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Spatial-frequency domain imaging (SFDI) |
| Control | Active comparator | Participants in this arm will be asked to complete SFDI and colorimeter measurements. Receives: Other: Spatial-frequency domain imaging (SFDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, 6 months.12 months
Secondary outcomes (7)
Ultrasound measurements of the forearms
A high frequency ultrasound scanner (GE Logiq e) with a 20 MHz transducer will be used to assess dermal thickness. Dermal thickness will be defined as the distance between the dermal-epidermal junction and the dermal-subcutaneous tissue interphase. Measurements will be taken at both the right and left border and the mean of these will be recorded as the dermal thickness score.
Measured: Baseline, 3 months, 6 months.12 months
Ultrasound measurements of the hands
A high frequency ultrasound scanner (GE Logiq e) with a 20 MHz transducer will be used to assess dermal thickness. Dermal thickness will be defined as the distance between the dermal-epidermal junction and the dermal-subcutaneous tissue interphase. Measurements will be taken at both the right and left border and the mean of these will be recorded as the dermal thickness score.
Measured: Baseline, 3 months, 6 months.12 months
Ultrasound measurements of the fingers
A high frequency ultrasound scanner (GE Logiq e) with a 20 MHz transducer will be used to assess dermal thickness. Dermal thickness will be defined as the distance between the dermal-epidermal junction and the dermal-subcutaneous tissue interphase. Measurements will be taken at both the right and left border and the mean of these will be recorded as the dermal thickness score.
Measured: Baseline, 3 months, 6 months.12 months
Durometry measurements of the forearm
Skin hardness will be measured using a hand-held digital durometer (Rex Gauge type OO; Rex Gauge, Buffalo Grove, IL). Three consecutive measurements will be taken at each forearm (center of dorsal aspect, midway between the radial head/styloid and lateral epicondyle). The mean of the 3 measurements at each site will be used.
Measured: Baseline, 3 months, 6 months.12 months
Durometry measurements of the hands
Skin hardness will be measured using a hand-held digital durometer (Rex Gauge type OO; Rex Gauge, Buffalo Grove, IL). Three consecutive measurements will be taken at each hand. The mean of the measurements at each site will be used.
Measured: Baseline, 3 months, 6 months.12 months
Collagen content of the forearm
Trichrome staining of a skin biopsy will be done to assess collagen content.
Measured: Baseline, 12 months
Scleroderma patient reported outcomes (SSPRO) scores
The SSPRO is a self-administered 18 item questionnaire to assess the effects of skin changes on physical, emotional and social well-being of SSc patients. Each question is rated on a scale from 0 (not much) to 6 (very much) with the maximum score being 108. Higher scores are associated with more adverse outcomes.
Measured: Baseline, 3 months, 6 months.12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start6 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be 60 patients with scleroderma and 5 control participants without scleroderma.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Andreea Bujor, MD, PhD, Principal investigator, BU Chobanian & Advesian School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090226
- Sponsor's protocol ID
- H-46158
- Other IDs
- R01AR085317-01
- Acronym
- SFDI
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Spatial Frequency Domain Imaging as an Objective Quantification of Longitudinal Skin Changes in Scleroderma
- ClinicalTrials.gov ID
- NCT07090226
- Acronym / sponsor ID
- SFDI / H-46158
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- The primary objective of this study is to validate spatial-frequency domain imaging (SFDI) and related optical techniques as robust, sensitive, and objective methods for quantifying skin involvement in systemic sclerosis. The study aims to use SFDI/SLIM to examine longitudinal skin changes in early diffuse cutaneous SSc patients and the correlation with change in modified Rodnan Skin Score (mRSS).
- Secondary objectives include assessing correlations between SFDI measurements of skin in SSc subjects and other clinical outcomes such as durometry, ultrasound, histopathological changes in the skin, or scleroderma patient reported outcomes (PROs).
In the current study longitudinal measurements in SSc patients will be taken to examine: the sensitivity and accuracy of SFDI to detect changes in skin thickness over time in response to therapy or from disease progression, the correlation between SFDI measurements and mRSS, and the expression of proteins including PDGFRβ in skin biopsy tissue.
In this study SFDI and other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness) will be compared. SFDI information will also be compared with capillaroscopy (that 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 as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be 60 patients with scleroderma and 5 control participants without scleroderma.
| Arm | Type | Receives |
|---|---|---|
| Scleroderma Participants | Experimental | Other: Spatial-frequency domain imaging (SFDI)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. |
| Control | Active comparator | Other: Spatial-frequency domain imaging (SFDI)Participants in this arm will be asked to complete SFDI and colorimeter measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control, Scleroderma Participants |
Primary outcome
Spatial-frequency domain imaging (SFDI) measurements of skin thickness
Time frame: Baseline, 3 months, 6 months.12 months
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.
Modified Rodnan skin score (mRSS) measurements of skin thickness
Time frame: Baseline, 3 months, 6 months.12 months
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.
7 secondary outcomes
Ultrasound measurements of the forearms
Time frame: Baseline, 3 months, 6 months.12 months
Ultrasound measurements of the hands
Time frame: Baseline, 3 months, 6 months.12 months
Ultrasound measurements of the fingers
Time frame: Baseline, 3 months, 6 months.12 months
Durometry measurements of the forearm
Time frame: Baseline, 3 months, 6 months.12 months
Durometry measurements of the hands
Time frame: Baseline, 3 months, 6 months.12 months
Collagen content of the forearm
Time frame: Baseline, 12 months
Scleroderma patient reported outcomes (SSPRO) scores
Time frame: Baseline, 3 months, 6 months.12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreea Bujor, MD, PhD principal investigator
BU Chobanian & Advesian School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial-frequency domain imaging (SFDI) in people with Systemic Scleroderma and Diffuse Cutaneous Scleroderma, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Chamis (617-358-6792, bchamis@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial-frequency domain imaging (SFDI) measurements of skin thickness (time frame: Baseline, 3 months, 6 months.12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.