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Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

NCT07228429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Systemic Sclerosis (SSc)
  • Calcinosis Cutis

Interventions

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

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Monique Hinchcliff, MD, MS · Yale University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07228429 on ClinicalTrials.gov