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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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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