NCT07090226 Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
| NCT ID | NCT07090226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | Systemic Scleroderma |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2025-11-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 a very imprecise, subjective method that varies amongst different doctors for the same patient is used 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). A previous plot study was conducted by the investigators to determine if spatial frequency domain imaging (SFDI), a method of light scattering, could be used to measure the collagen content in the skin of SSc patients. This non-painful, noninvasive method takes very little time and the investigators hypothesized that it would be more accurate than the "pinching" method. For that pilot study, patients with various stages of the disease were selected, and SFDI was used to image 6 areas. A forearm skin biopsy was taken for subsequent histopathology analyses of collagen content. The clinical mRSS was assessed at the time of SFDI measurement. Optical property imaging data was analyzed and statistically correlated and analyzed with immunohistochemistry (a method of identifying proteins) of the skin. Preliminary results demonstrated a strong correlation between mRSS and SFDI. Some of the imaging parameters of the SFDI were modified based on the initial results. Initial results demonstrated that the device can detect increases in skin thickness observed in SSc skin.
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.
Contact & Investigator
Andreea Bujor, MD, PhD
PRINCIPAL INVESTIGATOR
BU Chobanian & Advesian School of Medicine
Frequently Asked Questions
Who can join the NCT07090226 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Scleroderma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07090226 currently recruiting?
Yes, NCT07090226 is actively recruiting participants. Contact the research team at bchamis@bu.edu for enrollment information.
Where is the NCT07090226 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07090226 clinical trial?
NCT07090226 is sponsored by Boston University. The principal investigator is Andreea Bujor, MD, PhD at BU Chobanian & Advesian School of Medicine. The trial plans to enroll 65 participants.