Status:
UNKNOWN
Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
Conditions:
Systemic Sclerosis
Calcinosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This prospective placebo-controlled trial will enroll 20 patients with SSc and at least one calcinotic lesion of the hands that is palpable on physical examination and measurable on hand radiographs. ...
Detailed Description
1. Background: Calcinosis cutis is the deposition of calcium in the skin and subcutaneous tissues. It is a common and debilitating manifestation of systemic sclerosis (SSc), affecting 1 in 4 of th...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Age \> 18 years of age
- Diagnosis of limited or diffuse cutaneous systemic sclerosis (SSc) according to the revised 2013 ACR/EULAR classification criteria for SSc (21)
- Radiological and physical examination evidence of at least one subcutaneous calcium deposition in the hands that is clinically apparent as part of routine clinical care.
- If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits
- Oral corticosteroids (≤ 5 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for ≥ 2 weeks prior to screening and throughout the study
- Oral CCB, alpha-1-antagonists, ACE-inhibitors, angiotensin receptor blockers, and protein-pump inhibitors are permitted if the doses are stable for 4 weeks prior to screening and throughout the study.
Exclusion
- Rheumatic disease other than SSc
- Allergy to sodium metabisulfite
- Pregnant or nursing women
- Concurrent malignancy except non-melanoma skin cancers
- Patients receiving bisphosphonates, warfarin, colchicine, minocycline, intravenous immunoglobulins, or biological agents specifically abatacept or rituximab within 4 weeks of screening
- Patients receiving local treatments for calcinosis of the hands including surgical removal or intralesional steroid injections within 12 weeks of screening or throughout the study.
- Patients who have participated in another clinical trial of an investigative agent within 30 days of screening (or 5 half-lives of the investigational drug, whichever is longer)
- Patients with a history of drug or alcohol abuse within 6 months of screening
- Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
- Inability to comply with study and follow-up procedures
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06155578
Start Date
January 2 2024
End Date
December 31 2024
Last Update
December 4 2023
Active Locations (1)
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1
Antonia Valenzuela
Santiago, Chile, 8330077