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Intralesional Injection of STS in Treatment of Calcinosis

Study acronym: STSINJ
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Aug 31, 2025 to Aug 31, 2028
    • Study completion date: May 1, 2026 to May 1, 2029
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Start date: Dec 1, 2024 to Mar 17, 2025
    • Primary completion date: May 31, 2025 to Aug 31, 2025
    • Study completion date: Nov 2025 to May 1, 2026
    • Secondary endpoints revised (5)
    • Site details revised
  5. Start date: Nov 1, 2024 to Dec 1, 2024v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06672822
Lead Sponsor Robyn T. Domsic, MD, MPH
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)		 Systemic Sclerosis (SSc), Dermatomyositis, Mixed Connective Tissue Disease (MCTD), Calcinosis
Related terms Calcinosis, Dermatomyositis, Mixed Connective Tissue Disease, Scleroderma, Systemic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov