Intralesional Injection of STS in Treatment of Calcinosis (STSINJ)

An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatomyositis; Calcinosis; Mixed Connective Tissue Disease (MCTD); Systemic Sclerosis (SSc)
• Intervention / Treatment: Drug: Sodium Thiosulfate (STS)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maureen M Laffoon, BS; Phone Number: 412-648-7874; Email: laffoonm@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Arthritis and Autoimmunity Center
      • Contact: Office Manager; Phone Number: 412-647-6700; Email: sclerodermaappts@upmc.edu
      • Contact: Research Coordinator; Phone Number: 412-648-7871; Email: laffoonm@pitt.edu
      • Principal Investigator: Robyn T Domsic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium thiosulfate (STS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Robyn T. Domsic, MD, MPH
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Robyn T Domsis, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Boulman N, Slobodin G, Rozenbaum M, Rosner I. Calcinosis in rheumatic diseases. Semin Arthritis Rheum. 2005 Jun;34(6):805-12. doi: 10.1016/j.semarthrit.2005.01.016.
• Chander S, Gordon P. Soft tissue and subcutaneous calcification in connective tissue diseases. Curr Opin Rheumatol. 2012 Mar;24(2):158-64. doi: 10.1097/BOR.0b013e32834ff5cd.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: calcinosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Metabolic Diseases; Connective Tissue Diseases; Skin Diseases; Myositis; Calcium Metabolism Disorders; Polymyositis; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Dermatomyositis; Calcinosis; Mixed Connective Tissue Disease; Anti-Bacterial Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Antidotes; Antitubercular Agents; Chelating Agents; Sequestering Agents; sodium thiosulfate
• Other Study ID Numbers: STUDY24040146; 5P50AR080612 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No