Longitudinal Spatial Frequency Domain Imaging Study (SFDI)
Systemic Scleroderma
About this trial
This is an interventional other trial for Systemic Scleroderma focused on measuring Spatial frequency domain imaging (SFDI), modified Rodnan skin score (mRSS), Skin biopsy, Skin fibrosis, Scleroderma skin patient reported outcome (SSPRO), Durometry, Ultrasound
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Sites / Locations
- Shapiro Outpatient Rheumatology Clinic at Boston Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Scleroderma Participants
Healthy controls
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone at the first study visit and the SSPRO questionnaire at the time of enrollment and 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.
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire 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.