Intralesional Injection of STS in Treatment of Calcinosis
Recruiting
Phase 2
Interventional Study
Systemic Sclerosis (SSc)
Dermatomyositis
Mixed Connective Tissue Disease (MCTD)
Calcinosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Robyn T. Domsic, MD, MPH · Other
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About This Trial
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 p…
Trial Locations
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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.
* Parti…
Contacts