Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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. Each subject will undergo a screening evaluation 1 month before treatment with the study drug is initiated. Each subject will be instructed to blindly self-apply either topical 25% sodium metabisulfite or placebo cream twice daily. In-person follow-up evaluations will be performed after 4-months, with monthly telehealth follow-up visits to ensure adherence and arrange study drug refill deliveries.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pontificia Universidad Catolica de Chile
• Collaborator: Liga Panamericana de Asociaciones de Reumatologia (PANLAR)
• Treatments: Sodium metabisulfite

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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