Sodium Thiosulfate for Calcinosis

(STSINJ Trial)

Overseen By Maureen M Laffoon, BS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Robyn T. Domsic, MD, MPH

Disqualifiers: Pregnancy

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug sodium thiosulfate for treating calcinosis?

Intralesional sodium thiosulfate has shown promise in treating calcinosis cutis, with reports of complete resolution in some patients after treatment. Although there are no large-scale studies, smaller case reviews and pilot studies suggest it could be an effective option for managing this condition. ^{1 2 3 4 5}

Is sodium thiosulfate safe for treating calcinosis?

Sodium thiosulfate has been used in different forms to treat calcinosis, with some patients experiencing side effects like fatigue, nausea, and vomiting. However, intralesional injections have shown promise with minimal side effects, such as a temporary burning sensation during the injection. ^{1 2 3 5 6}

How is the drug sodium thiosulfate unique for treating calcinosis?

Intralesional sodium thiosulfate is unique because it is injected directly into the affected area, which can lead to complete resolution of calcinosis cutis with minimal side effects, unlike other treatments that have limited success. ^{1 2 3 5 7}

Research Team

Robyn T Domsis, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals with conditions like systemic sclerosis, lupus, dermatomyositis, and other connective tissue diseases who have calcinosis. Participants should have symptoms or lesions that can be measured. Specific eligibility criteria are not provided but typically include age limits and health status requirements.

Inclusion Criteria

I am over 18 years old.

My scans show calcium deposits in my body.

I am mentally capable of understanding and consenting to participate.

Exclusion Criteria

Pregnant women will be excluded

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intralesional sodium thiosulfate (STS) injections to calcinosis lesions

12 weeks

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Intralesional Injection of STS (Other)

Trial Overview The study tests the safety and effectiveness of Sodium Thiosulfate (STS) injections directly into calcified lesions in patients with certain connective tissue disorders. The size of the lesion will be monitored by ultrasound, and patient feedback on symptom relief will also be recorded.

Participant Groups

Group I: Sodium thiosulfate (STS) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Robyn T. Domsic, MD, MPH

Lead Sponsor

Trials

3

Recruited

200+

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

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a small pilot study involving 4 subjects, intralesional sodium thiosulfate showed limited efficacy for treating dystrophic calcinosis cutis, with only 1 subject experiencing improvement after 12 weeks.

There was no significant difference in lesion size between the sodium thiosulfate and normal saline groups, indicating that more research is needed to evaluate the effectiveness of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of intralesional sodium thiosulfate for the treatment of dystrophic calcinosis cutis: A double-blind, placebo-controlled pilot study. Winter, AR., Klager, S., Truong, R., et al.[2022]

Intralesional sodium thiosulfate was successfully used to treat calcinosis cutis in a patient with systemic sclerosis, leading to complete resolution of symptoms after three monthly injection sessions.

The treatment was well-tolerated, with only a mild transient burning sensation reported during injections, suggesting that sodium thiosulfate could be a safe and effective first-line therapy for calcinosis cutis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and ultrasound response to intralesional sodium thiosulfate for the treatment of calcinosis cutis in the setting of systemic sclerosis. A case-based review. López-Sundh, AE., Quintana-Sancho, A., Durán-Vian, C., et al.[2021]

Intravenous sodium thiosulfate (STS) was administered to three patients with long-standing dystrophic calcinosis cutis associated with connective tissue disease, but none showed significant clinical improvement after treatment.

All patients experienced side effects like fatigue and nausea during STS infusions, suggesting that while STS is being explored as a treatment, its efficacy in advanced cases of calcinosis cutis remains uncertain and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of response to intravenous sodium thiosulfate in three cases of extensive connective tissue disease-associated calcinosis cutis. Song, P., Fett, NM., Lin, J., et al.[2019]

Intralesional sodium thiosulfate was successfully used to treat 4 patients with calciphylaxis, leading to complete healing of their ulcers and remission of the disease.

The treatment was well-tolerated, with only minor localized discomfort reported during the injections, suggesting it may be a safer alternative to intravenous sodium thiosulfate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intralesional sodium thiosulfate for the treatment of calciphylaxis. Strazzula, L., Nigwekar, SU., Steele, D., et al.[2022]

Intralesional sodium thiosulfate (STS) has been successfully used to treat calcinosis cutis (CC) in a case series of 5 patients, demonstrating its efficacy in managing this challenging condition.

Ultrasound imaging played a crucial role in guiding the injections of STS and confirming the treatment's effectiveness, highlighting its utility in the management of CC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and ultrasonography follow-up of five cases of calcinosis cutis successfully treated with intralesional sodium thiosulfate. Tubau, C., Cubiró, X., Amat-Samaranch, V., et al.[2023]

Sodium thiosulphate (STS) demonstrated promising efficacy in treating tumoral calcinosis (TC) in four patients with end-stage renal disease, leading to rapid relief of pain and stiffness, and partial or total regression of TC after 11-14 months of treatment.

Despite some side effects like increased blood pressure and nausea during infusion, TC did not recur after treatment was stopped, with follow-up periods ranging from 1.5 to 12 years, suggesting STS could be a viable long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium thiosulphate treatment of uraemic tumoral calcinosis. Malbos, S., Urena-Torres, P., Cohen-Solal, M., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of intralesional sodium thiosulfate for the treatment of dystrophic calcinosis cutis: A double-blind, placebo-controlled pilot study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical and ultrasound response to intralesional sodium thiosulfate for the treatment of calcinosis cutis in the setting of systemic sclerosis. A case-based review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Lack of response to intravenous sodium thiosulfate in three cases of extensive connective tissue disease-associated calcinosis cutis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Intralesional sodium thiosulfate for the treatment of calciphylaxis. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Clinical and ultrasonography follow-up of five cases of calcinosis cutis successfully treated with intralesional sodium thiosulfate. [2023]

6. France pubmed.ncbi.nlm.nih.gov

Intravenous sodium thiosulfate for treating tumoral calcinosis associated with systemic disorders: Report of four cases. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Sodium thiosulphate treatment of uraemic tumoral calcinosis. [2015]