NCT05672992Active, not recruiting
Longitudinal Spatial Frequency Domain Imaging Study
Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 20 Dec 2022
- Start date
- 10 Feb 2023
- Primary completion date
- Sept 2028
- Lead sponsor
- Boston University
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05672992
What you commit to
- Study type: Interventional
- Participants enrolled: 78
- From 10 Feb 2023 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
Age
- Presence of other co-morbid illnesses with an estimated median life expectancy \< 5 years.
Other
- Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shapiro Outpatient Rheumatology Clinic at Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.