RecruitingRare disease

Study on Treating Calcinosis Cutis in Systemic Sclerosis Patients with Sodium Thiosulfate, Cetrimide, and Lidocaine

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called calcinosis cutis, which occurs in patients with systemic sclerosis. Systemic sclerosis is a rare disease that causes hardening and tightening of the skin and connective tissues. Calcinosis cutis involves the formation of calcium deposits in the skin, which can be painful and lead to complications. The treatment being investigated in this study is called sodium thiosulfate, which is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective and safe sodium thiosulfate is in treating calcinosis cutis in patients with systemic sclerosis. Participants in the study will receive sodium thiosulfate treatment and will be monitored over a period of time to see if there is a reduction in the calcium deposits. The study will use various methods, including imaging techniques, to assess changes in the condition of the skin and the size of the calcium deposits. These imaging techniques may include methods like MRI and other advanced scans to provide detailed pictures of the affected areas.

Throughout the study, participants will have regular check-ups to monitor their progress and any changes in their condition. The study aims to determine whether sodium thiosulfate can help reduce the size of the calcium deposits and improve the symptoms of calcinosis cutis. The results of this study could provide valuable information on a potential treatment option for patients with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to evaluate the current state of calcinosis cutis (CC) in systemic sclerosis (SSc).
This includes clinical evaluations and imaging to establish a baseline for the study.
Step 2
Treatment initiation
The treatment involves the administration of sodium thiosulfate as a solution for injection.
The medication is given through an intravenous infusion, targeting the CC lesions.
Step 3
Treatment schedule
The treatment is scheduled over a period of 28 weeks.
Assessments are conducted at week 1, week 5, week 17, week 21, and week 28 to monitor progress and response to the treatment.
Step 4
Monitoring and assessments
Throughout the study, the severity of CC lesions is monitored using various imaging techniques such as RCM, DECT, and CBCT.
Clinical assessments include evaluating ulcer size, inflammatory surroundings, and taking clinical photos.
Step 5
Evaluation of treatment efficacy
The primary goal is to achieve complete or partial remission of CC lesions, assessed through imaging and clinical evaluations.
Secondary assessments include changes in biomarkers and quality of life measures using the Short-form 36 and Health Assessment Questionnaire Disability Index.
Step 6
Final evaluation
At the end of the 28-week period, a final evaluation is conducted to determine the overall effectiveness of the treatment.
This includes a comprehensive review of imaging results, clinical assessments, and any changes in biomarkers.

Who can join the trial?

10 criteria

Have a condition called **calcinosis cutis** in **systemic sclerosis**. This means having calcium deposits in the skin due to a specific type of connective tissue disease.
Meet the criteria for **systemic sclerosis** (SSc) as defined by specific guidelines, or have a related condition called **mixed connective tissue disease** with overlap to SSc.
Provide signed, written informed consent, which means agreeing to participate after understanding the study details.
Be between 18 and 90 years old at the start of the study.
Be legally competent, meaning able to make decisions and give consent.
Be able to speak and write in Danish.
Be in good general health and willing to participate in the study.
Be willing and able to follow the study requirements and undergo all necessary tests.
Have stable medications for **systemic sclerosis** for at least 6 weeks before joining the study.
If previously treated with **sodium thiosulfate** (STS) on the selected lesion, a waiting period of 3 months must be completed before joining the study.

Who cannot join the trial?

7 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with severe kidney problems are excluded. This means if your kidneys are not working well, you cannot join.
People with a history of severe allergic reactions to sodium thiosulfate, the study medication, cannot take part. An allergic reaction is when your body reacts badly to something, like a rash or difficulty breathing.
Participants who are currently involved in another clinical trial are not allowed. This means if you are already part of another study, you cannot join this one.
Individuals with other serious health conditions that might interfere with the study are excluded. This means if you have another major illness that could affect the study results, you cannot participate.
Patients who have had a recent surgery or are planning to have surgery soon cannot join. Surgery means having an operation.
People who are unable to follow the study procedures or instructions are not allowed to participate. This means if you cannot understand or follow what the study requires, you cannot join.

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Verified sites

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Aarhus University Hospital
Verified
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

Sodium Thiosulfate is being studied for its potential to treat calcinosis cutis in patients with systemic sclerosis. This medication is administered directly into the affected areas to evaluate its effectiveness in reducing or eliminating the calcium deposits that characterize this condition. The study aims to determine how well sodium thiosulfate works in achieving remission of these lesions and to assess its safety for patients.

What is already known about the treatment

Sodium Thiosulfate – This medication is administered intralesionally, meaning it is injected directly into the affected area. It is currently being studied in clinical trials for its effectiveness in treating calcinosis cutis, a condition associated with systemic sclerosis. Sodium thiosulfate works by dissolving calcium deposits at the molecular level, which helps reduce the size and number of these deposits. It is classified as a chelating agent, which means it binds to certain substances in the body to help remove them.

Investigated diseases

Calcinosis cutis in systemic sclerosis – Calcinosis cutis is a condition characterized by the abnormal deposition of calcium salts in the skin and subcutaneous tissues. In the context of systemic sclerosis, a chronic connective tissue disease, these calcium deposits can form hard nodules or plaques, often leading to discomfort or skin ulceration. The progression of calcinosis cutis involves the gradual accumulation of calcium, which can vary in size and density, affecting different areas of the body, particularly the hands. Over time, these deposits may become more prominent and can interfere with normal skin function. The condition is often associated with inflammation and can be visually assessed through imaging techniques to monitor changes in the calcinosis volume and severity.