RecruitingPhase 2NCT06672822

Intralesional Injection of STS in Treatment of Calcinosis

An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease


Sponsor

Robyn T. Domsic, MD, MPH

Enrollment

20 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria1

  • Pregnant women will be excluded

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Interventions

DRUGSodium Thiosulfate (STS)

Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.


Locations(1)

UPMC Arthritis and Autoimmunity Center

Pittsburgh, Pennsylvania, United States

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NCT06672822


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