An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease
Robyn T. Domsic, MD, MPH
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.
Description
Calcinosis is a condition in which calcium builds up in the skin and tissue under the skin. It develops in ∼30% of adult dermatomyositis,18%-49% of systemic sclerosis patients, 25-40% of patients with limited systemic sclerosis. There is no standard treatment recommended by physicians currently. Many treatments have been tested, all with limited benefits and without good evidence that any are effective. They are, based only on single cases or small numbers of patients in studies called "case series." But in some cases, these agents may be effective. There are several case series that have sho…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- UPMC Arthritis and Autoimmunity CenterPittsburgh, Pennsylvania