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
Yale University
56 participants
Oct 14, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- Unable to provide informed consent
- Currently pregnant or nursing
- Patients with a calcinosis ROI >6cm
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Interventions
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07228429