Quantification of calcinosis cutis disease burden using computed tomography images
- Study IRB#:2000040280
- Last Updated:10/23/2026
The Yale Scleroderma Program is conducting a research study to evaluate methods for measuring calcinosis cutis (calcium deposits under the skin) and changes in disease burden over time in patients with systemic sclerosis (scleroderma).
The goal is to assess the performance of patient-reported questionnaires and computed tomography (CT) imaging to support future clinical trials of calcinosis treatments. Individuals diagnosed with systemic sclerosis and calcinosis cutis who are receiving treatment with topical sodium thiosulfate, citric acid, or sodium thiosulfate injections may be eligible to participate. Participation involves two in-person study visits over six months, including CT scans at baseline and six months, questionnaires at baseline, three months, and six months, and review of medical records.
Participants will continue receiving standard of care treatment as determined by their physician, with monthly treatment visits for those receiving sodium thiosulfate injections. Study related CT scans are provided at no cost to participants.
- Age18 years - 100 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Diane Documet
- Phone Number: 305-680-6419
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call 877-978-8343 for more information.
Study Location
- Yale University
Eligibility Criteria
Participants must have a diagnosis of systemic sclerosis (scleroderma) with calcinosis cutis (calcium deposits under the skin) and be receiving standard-of-care treatment with topical sodium thiosulfate, topical citric acid, or sodium thiosulfate injections. Participants must be willing to complete study questionnaires and undergo CT imaging at baseline and six months, with at least two in-person study visits over six months. Individuals with very large calcinosis lesions (greater than 6 cm) requiring surgical removal are not eligible. Additional eligibility requirements will be reviewed by the study team.
