RECRUITINGOBSERVATIONAL
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images
About This Trial
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
Who May Be Eligible (Plain English)
Who May Qualify:
- Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care
- Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
- Receiving clinical care at Yale clinics
Who Should NOT Join This Trial:
- Unable to provide willing to sign a consent form
- Currently pregnant or nursing
- Patients with a calcinosis ROI \>6cm
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care
* Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)
* Receiving clinical care at Yale clinics
Exclusion Criteria:
* Unable to provide informed consent
* Currently pregnant or nursing
* Patients with a calcinosis ROI \>6cm
Treatments Being Tested
DRUG
Sodium Thiosulfate (STS)
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
DRUG
Sodium Thiosulfate Injection
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Locations (1)
Yale Scleroderma Program
New Haven, Connecticut, United States