Calcinosis Cutis, Systemic Sclerosis (SSc)
Conditions
Brief summary
The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
Interventions
Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months
calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months
Sponsors
Yale University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scleroderma/systemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care * Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited) * Receiving clinical care at Yale clinics
Exclusion criteria
* Unable to provide informed consent * Currently pregnant or nursing * Patients with a calcinosis ROI \>6cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Mawdsley Calcinosis Questionnaire (mMCQ) | Baseline, 3 months and 6 months | An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis. |
| Calcinosis VAS | Baseline, 3 months and 6 months | Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity. |
| CT imaging measure | Baseline, 3 months and 6 months | BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the change in the mMCQ scores and the CT imaging measures | Baseline, 3 months and 6 months | Correlation between the change in the mMCQ scores (An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score) and the CT imaging measures (BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software.) |
Countries
United States
Contacts
CONTACTCrystal Cheung
CONTACTDiane Documet
PRINCIPAL_INVESTIGATORMonique Hinchcliff, MD, MS
Yale University
Outcome results
None listed