Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07228429
Status
Recruiting
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Conditions

  • Calcinosis Cutis
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
56 participants (estimated)

Arms

  • Arm: Systemic sclerosis participants with calcinosis
    SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months.

Primary Outcome Measure

Modified Mawdsley Calcinosis Questionnaire (mMCQ) [ Time Frame: Baseline, 3 months and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Scleroderma ProgramNew HavenConnecticut06520-

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