Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Pontificia Universidad Catolica de Chile

Collaborator:

Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

Treatments:

Sodium metabisulfite