Cutaneous calcification Trials in Disease

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

This clinical trial is investigating the treatment of calcinosis cutis, a condition where calcium deposits form in the skin, particularly in patients with systemic sclerosis. Systemic sclerosis is a rare disease that causes hardening and tightening of the skin and connective tissues. These calcium deposits can be painful and may lead to skin ulcers and other complications.

Who can participate:

To join this study, participants must meet several criteria. They need to have calcinosis cutis associated with systemic sclerosis or mixed connective tissue disease with overlap to systemic sclerosis. Participants must be between 18 and 90 years old, able to speak and write in Danish, and in good general health. They must have had stable medications for systemic sclerosis for at least 6 weeks before entering the study. If previously treated with sodium thiosulfate on the selected lesion, a waiting period of 3 months is required before joining. All participants must be able to provide informed consent, meaning they understand and agree to the study requirements, and must be willing to undergo all necessary tests and follow study procedures.

Who cannot participate:

Several conditions exclude people from this trial. Pregnant or breastfeeding women cannot participate. People with severe kidney problems or a history of severe allergic reactions to sodium thiosulfate are excluded. Those currently involved in another clinical trial or who have other serious health conditions that might interfere with the study cannot join. Patients who have recently had surgery or are planning surgery soon, as well as those unable to follow study procedures or instructions, are not allowed to participate.

Focus and goal of the trial:

The main goal of this study is to evaluate how effective and safe sodium thiosulfate is in treating calcinosis cutis. The treatment involves administering sodium thiosulfate directly into the bloodstream through intravenous infusion. The study lasts 28 weeks, with assessments conducted at weeks 1, 5, 17, 21, and 28 to monitor progress. Researchers will use various imaging techniques, including advanced scans like MRI, to assess changes in the calcium deposits and evaluate whether the treatment reduces their size. The study also monitors ulcer size, inflammation around the deposits, and takes clinical photos to track progress. Additionally, researchers will evaluate changes in biomarkers and quality of life measures to understand the overall impact of the treatment on patients.

Investigational drug:

The medication being tested is sodium thiosulfate, which is given as a solution through injection directly into the bloodstream. Sodium thiosulfate is classified as a chelating agent, meaning it works by binding to calcium deposits at the molecular level to help dissolve and remove them. This medication is being studied specifically for its potential to reduce or eliminate the calcium deposits that characterize calcinosis cutis in patients with systemic sclerosis.