Systemic SclerodermaSFDINCT05672992
Longitudinal Spatial Frequency Domain Imaging Study
A study testing Spatial-frequency domain imaging (SFDI) in people with Systemic 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
- What is being tested?
- Spatial-frequency domain imaging (SFDI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to Sep 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
- 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)
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods 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 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.
Read the detailed description
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.
- Conditions
- Systemic Scleroderma
- 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
- Medical subject headings
- Scleroderma, Systemic
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 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. Receives: 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. Receives: Other: Spatial-frequency domain imaging (SFDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline SFDI measurements of skin thickness
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months
Secondary outcomes (4)
Serum fibrosis biomarkers, Chemokines that promote fibrosis
Assessed from serum
Measured: baseline and every 12 months up to 36 months
Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
Assessed from serum
Measured: baseline and every 12 months up to 36 months
Serum fibrosis biomarkers, Matricellular proteins
Assessed from serum
Measured: baseline and every 12 months up to 36 months
histopathological assessments of skin collagen content
Assessed from skin biopsy samples
Measured: baseline and every 12 months up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start10 Feb 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 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
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Scleroderma Clinical Trials Consortium (SCTC), Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)
- Responsible party
- Sponsor
- Investigators
- Andreea Bujor, MD, PhD, Principal investigator, BU Chobanian & Advesian School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672992
- Sponsor's protocol ID
- H-43177
- Acronym
- SFDI
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
- ClinicalTrials.gov ID
- NCT05672992
- Acronym / sponsor ID
- SFDI / H-43177
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Scleroderma Clinical Trials Consortium (SCTC), Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Jan 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| 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 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. |
| Healthy controls | Active comparator | 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 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.
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 | Healthy controls, Scleroderma Participants |
Primary outcome
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
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
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
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
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
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
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
4 secondary outcomes
Serum fibrosis biomarkers, Chemokines that promote fibrosis
Time frame: baseline and every 12 months up to 36 months
Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
Time frame: baseline and every 12 months up to 36 months
Serum fibrosis biomarkers, Matricellular proteins
Time frame: baseline and every 12 months up to 36 months
histopathological assessments of skin collagen content
Time frame: baseline and every 12 months up to 36 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 14 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline SFDI measurements of skin thickness (time frame: baseline). The study lists 7 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 14 Jan 2026.