Intralesional Injection of STS in Treatment of Calcinosis

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Robyn T. Domsic, MD, MPH
Study ID
NCT06672822
Phase
PHASE2
Status
Recruiting
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Conditions

  • Calcinosis
  • Dermatomyositis
  • Mixed Connective Tissue Disease (MCTD)
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
May 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sodium thiosulfate (STS)
    Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.

Primary Outcome Measure

Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Arthritis and Autoimmunity CenterPittsburghPennsylvania15213
Office Manager
[email protected]
412-647-6700
Research Coordinator
[email protected]
412-648-7871
Robyn T Domsic, MD (PRINCIPAL_INVESTIGATOR)

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