SFDI imaging to measure skin fibrosis in diffuse cutaneous scleroderma
Assessing Spatial Frequency Domain Imaging as an Objective Quantification of Longitudinal Skin Changes in Scleroderma
This study tries SFDI, a painless light-based imaging method, to measure skin thickening in people with early diffuse cutaneous scleroderma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07090226 on ClinicalTrials.gov |
What this trial studies
This interventional study uses spatial-frequency domain imaging (SFDI) to quantify skin collagen and fibrosis over time in patients with early diffuse cutaneous systemic sclerosis. Participants will have serial SFDI scans alongside standard clinical measures including modified Rodnan skin score (mRSS), durometry, ultrasound, patient-reported skin outcomes (SSPRO), and optional skin biopsies for histology and PDGFRβ expression. The team will compare SFDI measurements with these clinical and histological outcomes to determine sensitivity to change and correlation with established measures. Healthy controls without autoimmune disease will be imaged for reference.
Who should consider this trial
Good fit: Adults diagnosed with diffuse cutaneous systemic sclerosis within roughly 2–5 years of diagnosis who can attend serial visits and are willing to undergo imaging and optional skin biopsies.
Not a fit: Patients with other forms of scleroderma (e.g., limited cutaneous), active wounds or rashes at imaging sites, recent skin malignancy, or those unable to travel to the Boston site are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, SFDI could provide a fast, objective, noninvasive way to detect and track skin fibrosis more accurately than the current pinch-based scoring method.
How similar studies have performed: A prior pilot study by the investigators showed promising correlations between SFDI measurements and skin collagen in mixed-stage patients, but longitudinal validation in early diffuse disease is still needed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Shapiro Outpatient Rheumatology Clinic at Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Andreea Bujor, MD, PhD — BU Chobanian & Advesian School of Medicine
- Study coordinator: Benjamin Chamis
- Email: bchamis@bu.edu
- Phone: 617-358-6792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.