Calcinosis cutis in SSc patients treated with sodium thiosulfate assessed by biomarkers and imaging
Key facts
- Where
- Aarhus N és Copenhagen Nv, DániaSee the 2 sites
- Phase
- 4. fázis
Where in Dánia
- Aarhus UniversitetshospitalAarhus N, DániaTaking people
- Copenhagen University HospitalCopenhagen Nv, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus Universitetshospital
- Trial code
- EU 2023-510255-34-00
- Record updated
- 2026. április 14.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.