An interventional study of Spatial-frequency domain imaging (SFDI) in Systemic Scleroderma and Diffuse Cutaneous Scleroderma, sponsored by Boston University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Boston University · Not applicable, Interventional, and Other
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.
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 65 is above the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusion criteria for providing a skin biopsy sample during the study but are not exclusions for enrollment in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Participants in this arm will be asked to complete SFDI and colorimeter measurements.
Other: 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.
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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months.12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months.12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Dec 2028, 37 months after the start.
Of 94 non-industry interventional studies with no phase under Scleroderma, Systemic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 37 months is above that.
Counting every sponsor, half of 100 studies reached it within 23 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.