Recruiting

Radiographic Techniques

Sponsor:

Yale University

Code:

NCT07228429

Conditions

Systemic Sclerosis (SSc)

Calcinosis Cutis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Thiosulfate (STS)

Sodium Thiosulfate Injection

Study Details

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.

Conditions

Systemic Sclerosis (SSc)

Calcinosis Cutis

Study ID

NCT07228429

Start date

Oct 14, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Interventions and Outcome Measures

Arms

Systemic sclerosis participants with calcinosis

SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.

Interventions

Sodium Thiosulfate (STS)

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

Sodium Thiosulfate Injection

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

Primary outcome measure

  • Modified Mawdsley Calcinosis Questionnaire (mMCQ) [ Time Frame: Baseline, 3 months and 6 months ]
  • Calcinosis VAS [ Time Frame: Baseline, 3 months and 6 months ]
  • CT imaging measure [ Time Frame: Baseline, 3 months and 6 months ]

Central Contacts and Locations

Central contacts

Crystal Cheung

203-737-5571crystal.cheung@yale.edu

Diane Documet

diane.documet@yale.edu

Locations

Yale Scleroderma Program

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-17.