2023-510255-34-00RecruitingPhase 4
Calcinosis cutis in SSc patients treated with sodium thiosulfate assessed by biomarkers and imaging
A prospective, multi-centre, open-label, investigator-initiated randomised controlled study investigating calcinosis cutis in patients with systemic sclerosis undergoing treatment with sodium thiosulfate assessed by novel biomarkers and diagnostic imaging
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Apr 2026
Brief summary (registry, in English)
This is a prospective, multi-centre, investigator-initiated randomized controlled study, with the overall objective of evaluating the efficacy and safety of intralesional sodium thiosulfate (STS) treatment in patients with calcinosis cutis (CC). The primary aim is to assess remission (complete/partial) in CC lesions during treatment with STS.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 21 Jun 2024
- Lead sponsor
- Aarhus Universitetshospital
- Diseases
- Systemic sclerosis (scleroderma)
- EU CT number
- 2023-510255-34-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 75
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Individuals with other skin diseases in the skin area of interest
- Known hypersensitivity to STS
Other
- Individuals with CC of other causality
- Individuals whose CC lesion is not accessible for imaging e.g., inside the ear, inside nostrils.
- Pregnancy
- Breastfeeding
- Women of child-bearing potential not using a contraceptive agent at the time of inclusion
Who the study is looking for
- SSc fulfilling ACA/EULAR 2013 criteria as well as patients with positive U1RNP and mixed connective tissue disease with overlap syndrome to SSc
- Provides signed, written informed consent
- Above 18 and under 90 years of age at baseline
- Legally competent, able to give verbal, written and informed consent
- Communicate in Danish verbally as well as in writing
- Subject in good general health and willing to participate
- Is willing and able to comply with the requirements of the protocol and to undergo all testing
- Medications for SSc are stable for at least 6 weeks prior to study entry
- If subjects received STS treatment on the selected lesion before, a washout period of 3 months must be complete upon study entry
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital | Aarhus N | Denmark | Recruiting |
| Copenhagen University Hospital | Copenhagen Nv | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.