CTIS2023-510255-34-00
Active, not recruiting
Phase 1
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
Aarhus Universitetshospital0 sites75 target enrollmentMarch 11, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Calcinosis cutis in systemic sclerosis
- Sponsor
- Aarhus Universitetshospital
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Individuals with other skin diseases in the skin area of interest, 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, Known hypersensitivity to STS
Outcomes
Primary Outcomes
Not specified
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