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NCT Number: NCT07228429

Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

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.

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Key information

Conditions

Systemic Sclerosis (SSc) Calcinosis Calcinosis Cutis Calcium Metabolism Disorders Connective Tissue Diseases Metabolic Diseases Nutritional and Metabolic Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale Scleroderma Program

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Thiosulfate (STS)

Drug

Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months

Sodium Thiosulfate Injection

Drug

calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months

Primary outcomes

  1. Modified Mawdsley Calcinosis Questionnaire (mMCQ)

    Time frame: 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.

  2. Calcinosis VAS

    Time frame: 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.

  3. CT imaging measure

    Time frame: 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 outcomes

  1. Correlation between the change in the mMCQ scores and the CT imaging measures

    Time frame: 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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal Cheung

CONTACT

[email protected]

203-737-5571

Diane Documet

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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