Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

Launched by BOSTON UNIVERSITY · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to measure skin thickening in people with diffuse cutaneous scleroderma, a condition where the skin and some internal organs become hard and tight due to extra collagen. Right now, doctors “pinch” the skin to estimate how thick it is, but this method can vary a lot between doctors and isn’t very precise. The study is testing a device called Spatial Frequency Domain Imaging (SFDI), which uses light to measure how much collagen is in the skin. This method is painless, quick, and may give a more accurate picture of skin changes than the traditional “pinching” test.

People who might join this study include adults aged 65 to 74 who have been diagnosed with diffuse cutaneous scleroderma within the past 2 to 5 years. Healthy volunteers without autoimmune diseases or skin problems can also take part as a comparison group. During the study, participants will have their skin scanned using the SFDI device, which is non-invasive and does not hurt. Some participants may also have a small skin biopsy (a tiny skin sample taken with local numbing) to compare with the imaging results, but this is optional and has some exclusions, such as allergies to anesthetics or certain health risks. The study is not yet recruiting, but it aims to improve how doctors assess skin changes in scleroderma, which could help in tracking disease progress and planning treatment.

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Eligibility criteria

• Inclusion Criteria:
• • Scleroderma (SSc) participants must have been diagnosed with SSc as defined by the American College of Rheumatology within the past 2-5 years AND fulfill criteria for diffuse cutaneous SSc according to LeRoy classification
• • Healthy controls must be free of SSc or other autoimmune disease and have no known skin pathology
• 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.
• • Exclusion criteria for providing a skin biopsy sample during the study but are not exclusions for enrollment in the study.
• • Subject has known allergy to lidocaine or has had a reaction to local anesthetics in the past will not provide skin biopsy samples at any time during the study.
• • Subjects who, in the opinion of the investigator, are high-risk for small tissue calcification, or other conditions that may affect wound healing will not provide skin biopsy samples at any time during the study.
• • Subjects who are pregnant or lactating are excluded from providing a skin biopsy sample only while they are pregnant or lactating.