Trial · NCT06672822
Intralesional Injection of STS in Treatment of Calcinosis
NCT06672822, Phase 2, Recruiting, Robyn T. Domsic, MD, MPH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intralesional Injection of STS in Treatment of Calcinosis. Trials, record NCT06672822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06672822
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intralesional Injection of STS in Treatment of Calcinosis
- NCT number
- NCT06672822
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Robyn T. Domsic, MD, MPH
- Conditions
- Systemic Sclerosis (SSc), Dermatomyositis, Mixed Connective Tissue Disease (MCTD), Calcinosis
- Interventions
- Sodium Thiosulfate (STS)
- First posted
- 2024-11-04
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks | 12 weeks | Change in size of calcinosis lesions will be measured by x-ray at baseline and then again at 12 weeks. |
| Secondary | Change in pain (interference) | up to 12 weeks | We will evaluate pain impact on quality-of-life using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference Short Form 4a. This is a 4-question patient-reported outcome measure asking patients about their experience in the last week. Responses are in a likert scale format from 'not at all' to 'very much' Higher scores indicate higher degrees of interference with important aspects of life. The raw score is converted to a T-score with a mean of 50 and a standard deviation (SD) of 10. |
| Secondary | Change in Pain Intensity | up to 12 weeks | We will measure pain intensity using the PROMIS® Pain Intensity 3a scale. This is a 30-item questionnaire inquiring about pain over the last week. Higher scores indicate higher pain intensity. Raw scores are converted to a T-score for analysis. The t-score is set to a mean of 50 and a standard deviation (SD) of 10. |
| Secondary | Health-related Quality of Life using the EQ-5D-5L | up to 12 weeks | EuroQol(EQ)-5D-5L is a validated self-reported patient questionnaire assessing five domains of health quality: pain/discomfort, mobility, self-care, activity and anxiety/depression plus a patient global assessment visual analog scale (VAS). Patients can report no, some problems or extreme problems (scored 1-3); the VAS is scored 0-100. Iull health is a score of 1 and values below zero are regarded as a state worse than death. |
| Secondary | Scleroderma Health Assessment Questionnaire (SHAQ) | up to 12 weeks | The SHAQ is composed of the standard Health Assessment Questionnaire (HAQ-DI)) plus additional visual analog scales to measure symptoms important in scleroderma: vascular, digital ulcers, lung, gastrointestinal, pain and patient global assessment. The HAQ-DI questions are scored 0-3. Higher scores indicate greater disability. |
| Secondary | Change in calcinosis related symptom severity | up to 12 weeks | The Mawdsley calcinosis scale consists of Part A and Part B. Part A asks about presence of calcinosis or ulcers overlying calcinosis. If the response is present, then Part B is completed. Part B consists of 17 questions inquiring over the last 2 weeks of symptoms. Responses are 0-10 from no limitation/not all to maximum/worst possible. Higher scores indicate higher symptom severity from calcinosis. |
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50AR080612 | Clinical-Translational Studies in Skin, Lung, and Vascular Complications in Systemic Sclerosis | LAFYATIS, ROBERT A. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES | 2022 to 2025 |
Source NIH RePORTER
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/NCT06672822
GET https://conductscience.org/api/trials/v1/NCT06672822/registered