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Study of Sodium Thiosulfate for Calcinosis

This study is looking at a treatment called Sodium Thiosulfate (STS) for calcinosis, a condition where calcium builds up in the skin and tissues. Calcinosis can affect people with systemic sclerosis (SSc), dermatomyositis, or mixed connective tissue disease (MCTD). Currently, there's no standard treatment for calcinosis. This study will involve injecting STS directly into the calcinosis lesions using ultrasound guidance. Researchers want to see if STS can reduce the size of these lesions and improve symptoms. The study plans to enroll 20 adults who have calcinosis and need symptom relief. The main goal is to see how much the lesion size changes after 12 weeks.

Study design
This is a small, open-label study, meaning both you and the study team will know what treatment you are receiving. It plans to include 20 participants.
What's involved
You would receive injections of Sodium Thiosulfate (STS) into your calcinosis lesions, guided by ultrasound. Lesion size will be measured by ultrasound, and you will report on your symptoms.
Compensation
Not stated in the trial record.
Follow-up
Your calcinosis lesion size will be measured at 12 weeks after starting the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06672822

Intralesional Injection of STS in Treatment of Calcinosis

Recruiting
PHASE2Ages 18+InterventionalTreatment
Robyn T. Domsic, MD, MPH
~20 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Sodium Thiosulfate (STS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks
Measured over 12 weeks

Conditions

Systemic Sclerosis (SSc)
Dermatomyositis
Mixed Connective Tissue Disease (MCTD)
Calcinosis

Explore related trials

CalcificationDermatomyositisMixed Connective Tissue DiseaseSystemic Scleroderma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Robyn T Domsis, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Maureen M Laffoon, BS
[email protected]
412-648-7874
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks12 weeks

    Change in size of calcinosis lesions will be measured by x-ray at baseline and then again at 12 weeks.