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Taking people in DenmarkPhase 4

Sodium thiosulfate injections for calcium deposits in skin of people with systemic sclerosis

Tests sodium thiosulfate injected into calcium skin lumps in adults with systemic sclerosis.

Key facts

Who runs it
Aarhus Universitetshospital
Where
Aarhus N and Copenhagen Nv, DenmarkSee the 2 sites
Registry title
Calcinosis cutis in SSc patients treated with sodium thiosulfate assessed by biomarkers and imaging
Status
Recruiting
Phase
Phase 4
People taking part
75 people, planned
Started
21 Jun 2024
Expected to end
30 Dec 2029
Type of study
Interventional
Record updated
14 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with systemic sclerosis (SSc) who have calcium deposits in the skin (calcinosis cutis) and will be treated with sodium thiosulfate (STS) injected into the lesion.

Age
Above 18 and under 90 years
Sex
All sexes
Disease stage
Systemic sclerosis meeting the ACA/EULAR 2013 criteria, or positive U1RNP, or mixed connective tissue disease overlapping with SSc. The calcium lesion must be reachable for imaging.
Earlier treatment
SSc medicines must have been stable for at least 6 weeks before joining. If the same lesion had STS before, a 3-month break must be complete.
Biomarker or test result
Positive U1RNP is one of the ways in.

Main reasons for not taking part

  • Other skin diseases in the skin area of interest
  • Calcium deposits in the skin from another cause
  • Lesion that cannot be reached for imaging, e.g. inside the ear or nostrils
  • Pregnancy or breastfeeding
  • Known hypersensitivity to STS

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Individuals with other skin diseases in the skin area of interest
  • Known hypersensitivity to STS
  • 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

Where in Denmark

  • Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
  • Copenhagen University HospitalCopenhagen Nv, DenmarkTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Sodium thiosulfate injections for calcium deposits in skin of people with systemic sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
14 April 2026