NCT06672822 Intralesional Injection of STS in Treatment of Calcinosis
| NCT ID | NCT06672822 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Robyn T. Domsic, MD, MPH |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-03-17 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Robyn T Domsis, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06672822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06672822 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06672822 currently recruiting?
Yes, NCT06672822 is actively recruiting participants. Contact the research team at laffoonm@pitt.edu for enrollment information.
Where is the NCT06672822 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06672822 clinical trial?
NCT06672822 is sponsored by Robyn T. Domsic, MD, MPH. The principal investigator is Robyn T Domsis, MD at University of Pittsburgh. The trial plans to enroll 20 participants.