drugset / Trial / NCT06672822
Intralesional Injection of STS in Treatment of Calcinosis
Phase 2
Recruiting
20 enrolled
Robyn T. Domsic, MD, MPH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-03-17
- Primary completion
- 2028-08-31
- Completion
- 2029-05-01
Publications
- Results Boulman N, Slobodin G, Rozenbaum M, Rosner I. Calcinosis in rheumatic diseases. Semin Arthritis Rheum. 2005 Jun;34(6):805-12. doi: 10.1016/j.semarthrit.2005.01.016.
- Results Chander S, Gordon P. Soft tissue and subcutaneous calcification in connective tissue diseases. Curr Opin Rheumatol. 2012 Mar;24(2):158-64. doi: 10.1097/BOR.0b013e32834ff5cd.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Thiosulfate | Diagnostic / imaging agent | 250 mg/ml | Subcutaneous |