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

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with systemic sclerosis (SSc) who have calcinosis, which is the buildup of calcium deposits in the skin, particularly on the hands. The trial will involve 20 adult participants who will either use a special cream containing 25% sodium metabisulfite or a placebo cream that does not contain the active ingredient. The goal is to see if the sodium metabisulfite cream is safe and effective in reducing these calcium deposits. Participants will apply the cream twice daily for four months and have follow-up evaluations to monitor their progress.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of systemic sclerosis, and show evidence of at least one calcium deposit in their hands. Women who can become pregnant will need to have a negative pregnancy test before starting the trial. Those with other rheumatic diseases, certain allergies, or who are pregnant or nursing will not be eligible. Participants will receive careful monitoring throughout the study, including in-person visits and monthly telehealth check-ins, ensuring they can follow the study guidelines and receive any needed supplies. This trial is not yet recruiting, but it aims to provide valuable information about a potential new treatment option for those affected by this challenging condition.

Gender

ALL

Eligibility 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