Longitudinal Spatial Frequency Domain Imaging Study
Running, not enrolling · Not applicable
Conditions studied: Systemic Scleroderma
In brief
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.
Key facts
- Study ID
- NCT05672992
- Run by
- Boston University
- People needed
- 78
- Starts
- 2023-02-10
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Shapiro Outpatient Rheumatology Clinic at Boston Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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