Sodium Thiosulfate for Calcinosis

(STSINJ Trial)

Overseen By Maureen M Laffoon, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Robyn T. Domsic, MD, MPH

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using sodium thiosulfate (STS) injections to reduce the size and symptoms of calcinosis (calcium deposits under the skin) in individuals with systemic sclerosis, mixed connective tissue disease, or dermatomyositis. Researchers aim to determine the safety and effectiveness of ultrasound-guided injections. Suitable candidates for this trial include those diagnosed with one of these conditions who seek relief from calcinosis symptoms. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early understanding of its potential benefits.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that sodium thiosulfate (STS) may help treat calcinosis, a condition where calcium builds up under the skin. Studies suggest that STS can dissolve these calcium deposits, potentially benefiting conditions like systemic sclerosis and dermatomyositis.

STS has been used in various forms, such as creams applied to the skin or injections into a vein, and these treatments have generally been well-tolerated. For example, when used as a cream, only 2% of patients reported mild side effects, indicating that STS is quite safe and most people do not experience major issues.

In the current trial, STS is injected directly into the calcium deposits. Although this method is new, the safety of STS in other forms provides some confidence in its potential safety for this use.

Since this trial is in an early stage, it primarily focuses on the treatment's safety. Safety information is still being collected, but the evidence so far is reassuring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sodium thiosulfate (STS) is unique because it offers a new approach to treating calcinosis by directly targeting the calcium deposits with intralesional injections. Unlike standard treatments like pain management or surgical removal, which can be invasive and not always effective, STS aims to dissolve the calcium deposits from within. Researchers are excited about this treatment because it not only has the potential to be less invasive but also offers a more direct method of addressing the root cause of calcinosis, which could lead to better outcomes for patients.

What evidence suggests that this treatment might be an effective treatment for calcinosis?

Research has shown that sodium thiosulfate (STS) might help treat calcinosis, a condition characterized by calcium buildup in the body. In one case, a patient experienced significant improvement in a large calcium deposit after receiving direct STS injections. Another study found that injecting STS into the affected area reduced pain and decreased the size of calcium deposits in some patients. While these findings are encouraging, they mostly derive from small studies or individual cases. More research is needed, but early results suggest STS could alleviate calcinosis symptoms. Participants in this trial will receive STS injections to further evaluate its effectiveness. ^{2 5 6 7 8}

Who Is on the Research Team?

Robyn T Domsis, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 have been diagnosed with systemic sclerosis, mixed connective tissue disease, or inflammatory myopathy.

I am over 18 years old.

My scans show calcium deposits in my body.

Exclusion Criteria

Pregnant women will be excluded

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Intralesional Injection of STS

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Intravenous sodium thiosulfate (ivSTS) was administered to 4 patients with tumoral calcinosis (TC) related to autoimmune diseases, showing clinical improvement in 2 adults and 1 child after treatment, despite previous unsuccessful therapies.

While ivSTS helped manage symptoms like joint pain and inflammation, it did not significantly change the calcified lesions in TC, indicating the need for further research to understand its effects and determine the best treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous sodium thiosulfate for treating tumoral calcinosis associated with systemic disorders: Report of four cases. Mageau, A., Guigonis, V., Ratzimbasafy, V., et al.[2020]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37976811/

Effectiveness of topical sodium thiosulfate for ectopic ... Topical STS was clinically effective in 9/28 (32.1 %) patients with ECs and 2/7 (28.6 %) children with HOs. Three patients experienced complete disappearance of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03267277

Sodium Thiosulfate for Treatment of Calcinosis Associated ... A few reports in the literature describe treatment successes with a variety of therapeutics; however, these data are from anecdotal reports or case series and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049017223001488

Effectiveness of topical sodium thiosulfate for ectopic ... Topical STS was clinically effective in 9/28 (32.1 %) patients with ECs and 2/7 (28.6 %) children with HOs. Three patients experienced complete disappearance ...

4. jaadcasereports.org jaadcasereports.org/article/S2352-5126(24)00287-X/fulltext

Undiluted 25% intralesional sodium thiosulfate in the ... This is the first report of significant improvement of a large, dystrophic calcinosis cutis lesion from undiluted 25% STS therapy. As such, it ...

5. ard.bmj.com ard.bmj.com/content/77/Suppl_2/1537.2

AB0814 Sodium thiosulfate 10% intralesional to treat ... The primary endpoints were: pain relief evaluated through visual analogue scale (VAS) and reduction of major diameters of calcinosis in x-ray. The secondary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10743828/

Systemic Sodium Thiosulfate as an Adjunct Treatment in ... Based on our experience and literature data, systemic sodium thiosulfate may be a potential adjunct therapy in calcinosis, especially if inflamed or ulcerating.

7. jaad.org jaad.org/article/S0190-9622(21)02486-5/fulltext

Topical sodium thiosulfate as treatment of calcinosis cutis Furthermore, the tolerability and safety profile for these medications was favorable, with only 1 patient (2%) experiencing side effects—a mild ...

8. jaadcasereports.org jaadcasereports.org/article/S2352-5126(19)30473-4/fulltext

Successful treatment of calcinosis cutis of fingertip in the ... Sodium thiosulfate (STS) is an inorganic salt, which increases calcium solubility and has been reported to be helpful in treating calcinosis.