Using advanced imaging to track skin changes in scleroderma patients
Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
NA · Boston University · NCT05672992
This study is testing a new imaging technique to see if it can better track skin changes in people with scleroderma over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05672992 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of spatial frequency domain imaging (SFDI) in measuring skin thickness and fibrosis in patients with systemic scleroderma over time. The study will involve 60 scleroderma patients and 32 healthy controls, with measurements taken every three months for the first year and then every six months for up to three years. Participants will also have the option to provide blood samples and undergo skin biopsies to further assess skin changes and biomarkers. The goal is to provide a more objective and precise method for monitoring skin fibrosis compared to current subjective assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with systemic scleroderma or those suspected of having the condition based on clinical symptoms.
Not a fit: Patients with skin malignancies, significant skin conditions at measurement sites, or other serious co-morbid illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring of skin fibrosis in scleroderma patients, improving treatment outcomes.
How similar studies have performed: While the use of SFDI is a novel approach in this context, similar imaging techniques have shown promise in other studies for assessing skin conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
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: Britte Beaudette-Zlatanova, PhD
- Email: britte@bu.edu
- Phone: 617-358-6171
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.
Conditions: Systemic Scleroderma, Spatial frequency domain imaging, modified Rodnan skin score, Skin biopsy, Skin fibrosis, Scleroderma skin patient reported outcome, Durometry, Ultrasound