Intralesional Injection of STS in Treatment of Calcinosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobyn T. Domsic, MD, MPH
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 patient-reported outcome measures.
Eligibility criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Sodium Thiosulfate (STS)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Robyn T. Domsic, MD, MPH
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov