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

NCT06155578 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Topical 25% sodium metabisulfite (SM) in pediatric cold cream

Topical 25% sodium metabisulfite (SM) in pediatric cold cream will be applied twice daily on hand calcinosis.

DRUG

Placebo

Pediatric cold cream will be applied twice daily on hand calcinosis.

Sponsors & Collaborators

  • Liga Panamericana de Asociaciones de Reumatologia (PANLAR)

    collaborator OTHER

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Antonia Valenzuela, MD, MS · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Chile

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06155578 on ClinicalTrials.gov