A Phase 2 interventional study of Sodium Thiosulfate (STS) in Systemic Sclerosis (SSc), Dermatomyositis and Mixed Connective Tissue Disease (MCTD), sponsored by Robyn T. Domsic, MD, MPH. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Robyn T. Domsic, MD, MPH · Phase 2, Interventional, and Treatment
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.
Calcinosis is a condition in which calcium builds up in the skin and tissue under the skin. It develops in ∼30% of adult dermatomyositis,18%-49% of systemic sclerosis patients, 25-40% of patients with limited systemic sclerosis. There is no standard treatment recommended by physicians currently. Many treatments have been tested, all with limited benefits and without good evidence that any are effective. They are, based only on single cases or small numbers of patients in studies called "case series." But in some cases, these agents may be effective.
There are several case series that have shown the effectiveness of injecting a chemical compound called sodium thiosulfate (or "STS") into calcinosis lesions. There was some improvement in terms of pain control, and a decrease in size and resolution of the calcinosis. The aim of our study is to test intralesional sodium thiosulfate (STS) injection for symptoms relief of calcinosis. STS has been approved by the U.S. Food and Drug Administration for certain conditions related to childhood cancers. It has not been approved by the FDA to treat calcinosis. The specific aims of this study are to assess change in calcinosis size and quality-of-life measures.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 446 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Robyn T. Domsic, MD, MPH is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.
Drug: Sodium Thiosulfate (STS)
Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.
Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks
Change in size of calcinosis lesions will be measured by x-ray at baseline and then again at 12 weeks.
Time frame: 12 weeks
Change in pain (interference)
We will evaluate pain impact on quality-of-life using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference Short Form 4a. This is a 4-question patient-reported outcome measure asking patients about their experience in the last week. Responses are in a likert scale format from 'not at all' to 'very much' Higher scores indicate higher degrees of interference with important aspects of life. The raw score is converted to a T-score with a mean of 50 and a standard deviation (SD) of 10.
Time frame: up to 12 weeks
Change in Pain Intensity
We will measure pain intensity using the PROMIS® Pain Intensity 3a scale. This is a 30-item questionnaire inquiring about pain over the last week. Higher scores indicate higher pain intensity. Raw scores are converted to a T-score for analysis. The t-score is set to a mean of 50 and a standard deviation (SD) of 10.
Time frame: up to 12 weeks
Health-related Quality of Life using the EQ-5D-5L
EuroQol(EQ)-5D-5L is a validated self-reported patient questionnaire assessing five domains of health quality: pain/discomfort, mobility, self-care, activity and anxiety/depression plus a patient global assessment visual analog scale (VAS). Patients can report no, some problems or extreme problems (scored 1-3); the VAS is scored 0-100. Iull health is a score of 1 and values below zero are regarded as a state worse than death.
Time frame: up to 12 weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
The SHAQ is composed of the standard Health Assessment Questionnaire (HAQ-DI)) plus additional visual analog scales to measure symptoms important in scleroderma: vascular, digital ulcers, lung, gastrointestinal, pain and patient global assessment. The HAQ-DI questions are scored 0-3. Higher scores indicate greater disability.
Time frame: up to 12 weeks
Change in calcinosis related symptom severity
The Mawdsley calcinosis scale consists of Part A and Part B. Part A asks about presence of calcinosis or ulcers overlying calcinosis. If the response is present, then Part B is completed. Part B consists of 17 questions inquiring over the last 2 weeks of symptoms. Responses are 0-10 from no limitation/not all to maximum/worst possible. Higher scores indicate higher symptom severity from calcinosis.
Time frame: up to 12 weeks
Plan to share: Yes — Data should be requested by contacting the P0I once results are published. Data sharing will conform to all local and federal regulations and be de-identified with data use agreements in place.
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Studies of the drug tested here: Sodium thiosulfate
Robyn T. Domsic, MD, MPH