Intralesional Injection of STS in Treatment of Calcinosis

NCT ID: NCT06672822

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2029-05-01

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.

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.

Conditions

Systemic Sclerosis (SSc); Dermatomyositis; Mixed Connective Tissue Disease (MCTD); Calcinosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sodium thiosulfate (STS)

Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.

Group Type: EXPERIMENTAL

Sodium Thiosulfate (STS)

Intervention Type: DRUG

Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Robyn T. Domsic, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Robyn T. Domsic, MD, MPH

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robyn T Domsis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Arthritis and Autoimmunity Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maureen M Laffoon, BS

Role: CONTACT

laffoonm@pitt.edu

412-648-7874

Facility Contacts

Office Manager

Role: primary

sclerodermaappts@upmc.edu

412-647-6700

Research Coordinator

Role: backup

laffoonm@pitt.edu

412-648-7871

References

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.

Reference Type: BACKGROUND

PMID: 15942915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22227955 (View on PubMed)

Other Identifiers

5P50AR080612

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY24040146

Identifier Type: -

Identifier Source: org_study_id