Validating New Outcomes to Support Systemic Sclerosis Calcinosis Trials
Official title: Validating Novel Outcomes to Enable Systemic Sclerosis Calcinosis Cutis Clinical Trials
Funded at Yale University · NIH-11402752 · Data updated 2026-11-12
A patient-facing look at a study to test reliable ways to measure changes in painful skin calcium deposits from systemic sclerosis to help run future treatments.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Yale University NIH-funded |
| Lab location | 1 site (New Haven, United States) |
| Project start | September 1, 2025 |
| Project end | July 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $237,464 |
| NIH project number | 5R01AR085316-02 |
| Project ID | NIH-11402752 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with symptomatic calcinosis due to systemic sclerosis who are seeking treatment for a calcinosis region of interest and are willing to participate.
✕Less likely to help
Patients not experiencing calcinosis or not seeking treatment for a calcinosis ROI may not directly benefit.
What this research studies
This grant aims to test two measurable outcomes for calcinosis in systemic sclerosis: a patient questionnaire and a CT imaging score. Fifty-six participants from the Yale Scleroderma Program will be recruited and may receive topical or injected sodium thiosulfate to help drive changes in calcinosis during the study period. Participants will complete the Mawdsley Calcinosis Questionnaire at baseline, 3 months, and 6 months to track symptoms and impact on daily life. The study will use imaging and patient-reported data to determine which outcome measures best reflect changes over time. Results could enable smoother, more reliable evaluation of future therapies for calcinosis in systemic sclerosis.
Why it matters
Potential benefit: If successful, the project could provide validated, patient-friendly outcome tools that make it easier to test and approve new treatments for calcinosis.
How similar studies have gone: Previous work has explored patient-reported outcomes and imaging measures, but high-quality validated tools for SSc calcinosis are still needed.
Where this research is happening
-
Yale University
New Haven, United States Active
Researchers
- Principal investigator: Hinchcliff, Monique Evangeline — Yale University
- Study coordinator: Hinchcliff, Monique Evangeline
Related research
Other NIH-funded projects on the same topics.
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Understanding how a cell protein (SLC9A1) drives skin and lung scarring in systemic sclerosis
A five-year NIH grant aims to understand how a specific cell protein called SLC9A1 influences scar-forming cells in systemic sclerosis and related lung disease, with the goal of finding possible therapies.
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From proteins and genes to new treatments for scar-related lung disease
A large NIH grant is working to map the proteins in the lungs of people with systemic sclerosis to find new targets for drugs that could slow or stop lung fibrosis.
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Cell-level clues to skin scarring in systemic sclerosis and localized scleroderma
A study at the University of Pittsburgh is looking at how skin cells and their helpers change at the DNA level in adults and children with systemic sclerosis to find new targets to reduce scarring.
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Clinical-Translational Studies in Skin, Lung, and Blood Vessel Problems in Systemic Sclerosis
A NIH grant supports coordinated efforts to understand and improve health for people with systemic sclerosis and related conditions by sharing resources, data, and pilot projects at MUSC.
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Role of A20 and DREAM in fat cells and skin scarring in systemic sclerosis
A research project at the University of Michigan looks at how differences in fat tissue and blood vessels relate to skin scarring in systemic sclerosis, with the aim of finding new ways to treat or prevent fibrosis.
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Vasculopathy in Systemic Sclerosis and Lung Disease in Adults
A study in adults with systemic sclerosis will look at how blood vessels in the lungs and body relate to the development of lung disease, with the aim of finding new ways to prevent it.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.