Injection of sodium thiosulfate for treating calcinosis
Official title: An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease
Run by University of Pittsburgh · NCT06672822 · Data updated 2026-11-12
This study is testing if injections of sodium thiosulfate can safely help people with calcinosis related to conditions like systemic sclerosis and dermatomyositis feel better and reduce their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | August 31, 2028 |
| Study ends | May 1, 2029 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06672822 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a clinical diagnosis of systemic sclerosis, mixed connective tissue disease, or inflammatory myopathy who have radiographic evidence of calcinosis.
✕Probably not a fit
Patients who are pregnant or do not have calcinosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the safety and effectiveness of intralesional injections of sodium thiosulfate (STS) for patients suffering from calcinosis associated with systemic sclerosis, dermatomyositis, and mixed connective tissue disease. The injections will be guided by ultrasound, and the outcomes will be measured through ultrasound assessments of lesion size and patient-reported symptom relief. Currently, there are no standard treatments for calcinosis, making this approach particularly significant. The study is designed as a small, open-label Phase 2 trial to gather preliminary data on the potential benefits of STS injections.
Why it matters
Potential benefit: If successful, this treatment could provide significant symptom relief and reduction in lesion size for patients with calcinosis.
How similar studies have gone: Previous case series have shown some effectiveness of sodium thiosulfate injections for calcinosis, but this study represents a more structured investigation into its efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy * Must be over 18 years of age * Participants must be competent to give informed consent * Participants must have radiographic evidence (xray or ultrasound) of calcinosis. * Participants must need symptomatic relief Exclusion Criteria: • Pregnant women will be excluded
Where it's running
-
UPMC Arthritis and Autoimmunity Center
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Robyn T Domsis, MD — University of Pittsburgh
- Study coordinator: Maureen M Laffoon, BS
- Email: laffoonm@pitt.edu
- Phone: 412-648-7874
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.