Trial · NCT06155578
Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis
NCT06155578, Phase 1, Phase 2, Unknown, Pontificia Universidad Catolica de Chile
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis. Trials, record NCT06155578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06155578
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Topical Sodium Metabisulfite for the Treatment of Calcinosis in Patients With Systemic Sclerosis
- NCT number
- NCT06155578
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Conditions
- Systemic Sclerosis, Calcinosis
- Interventions
- Topical 25% sodium metabisulfite (SM) in pediatric cold cream, Placebo
- First posted
- 2023-12-04
- Last updated
- 2023-12-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the safety and tolerability of using topical 25% SM applied twice daily in SSc patients with calcinosis affecting the hands | 4 months | The primary assessment of safety will be the development of adverse events. Any significant changes to the subject's medical condition, physical examination, and concomitant medications will be documented throughout the course of the study. Any untoward medical experience will be recorded as an adverse event. |
| Primary | To assess the efficacy of topical 25% SM versus placebo in stabilizing the calcinosis burden or reducing the radiographic progression of calcinosis over four months. | 4 months | Radiograph of the hands will be scored using the SCTC radiographic calcinosis scroing system |
| Secondary | To assess the effect of topical 25% SM on the change in the Mawdsley Calcinosis Questionnaire, and patient and physician assessment of calcinosis severity over four months. | 4 months | The MCQ is a novel patient reported outcome measure developed to assess the severity and impact of SSc-related calcinosis in clinical studies/clinical practice. The content of this questionnaire is patient-generated and includes 17 questions related to the impact of calcinosis rated from 0 (no limitation) to 10 (worst limitation possible), organized in 6 items of quantification of calcinosis, a test question of interpretation and 3 domains: Pain/sensation (5 items); Physical Function (4 items) and Psychological Impact (6 items). Patients will fill up the MCQ at baseline and 4 months. |
| Secondary | To assess the effect of topical 25% SM on the change in size of calcinosis on ultrasound. | 4 months | US is a rapid and noninvasive technique that can provide in-vivo information for the detection and monitoring of calcium depositions. (25) Calcinosis in US can be identified as hyperechoic lesions with or without shadowing, located in the skin, soft tissue, tendons, peritendinous or periarticular areas. Length, width, and depth of calcinotic deposits will be measured in millimeters (mm) at baseline and 4 months using high-frequency color Doppler ultrasound examination. |
| Secondary | To assess the presence of markers of vascular damage and inflammation by tape stripping in SSc patients with calcinosis. | 4 months | Tape stripping is a non-invasive and largely used technique. The sampling of consecutive subcutaneous layers by means of glues on tapes allows to evaluate the composition of the skin, and to study the development of inflammatory mediators, wound healing, and other processes. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06155578
GET https://conductscience.org/api/trials/v1/NCT06155578/registered