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Recruiting Phase 2 NCT06672822

Intralesional Injection of STS in Treatment of Calcinosis

Trial Parameters

Condition Systemic Sclerosis (SSc)
Sponsor Robyn T. Domsic, MD, MPH
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-17
Completion 2028-08-31
Interventions
Sodium Thiosulfate (STS)

Brief Summary

The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.

Eligibility 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

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