Clinical trial for Systemic Scleroderma
Official title Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
ClinicalTrials.gov ID: NCT07090226
What this study is testing
- What it's testing
- The study wants to find out if spatial frequency domain imaging can accurately measure skin collagen compared with the usual pinch test.
- Who it's for
- Adults who have diffuse cutaneous systemic scleroderma.
- What's involved
- Participants will have non‑painful skin imaging with SFDI on several body areas, a skin biopsy, and the standard skin‑thickness score performed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Diagnosed with SSc as defined by the American College of Rheumatology within the past 5 years AND fulfill criteria for diffuse cutaneous SSc...
- 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...
- Healthy controls must be free of SSc or other autoimmune disease and have no known skin pathology
You likely can't join if
- Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma...
- 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.
- 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...
- people who, in the opinion of the investigator, are high-risk for small tissue calcification, or other conditions that may affect wound healing will...
- people who are pregnant or lactating are excluded from providing a skin biopsy sample only while they are pregnant or lactating.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.