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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scleroderma (SSc) participants:
* Diagnosed with SSc as defined by the American College of Rheumatology within the past 5 years AND fulfill criteria for diffuse cutaneous SSc according to LeRoy classification
* Diagnosed with SSc as defined by the American College of Rheumatology within the past 3 years AND have documented evidence of RNA Polymerase III or anti-topoisomerase antibody positivity
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Spatial-frequency domain imaging (SFDI) measurements of skin thickness
Timeframe: Baseline, 3 months, 6 months.12 months
2
Modified Rodnan skin score (mRSS) measurements of skin thickness