An observational study in Scleroderma, sponsored by The Hospital for Sick Children. Enrolling by invitation at 1 site in Canada. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by The Hospital for Sick Children · Observational
Localized scleroderma (LS) is a skin disease that can cause complications such as disfigurement and limitation of mobility. Treatment for LS should be initiated early in the disease, as late-stage scleroderma does not respond well to treatment. Objective tools for diagnosis and follow-up of treatment for LS are not available clinically and are urgently needed. A new non-invasive ultrasound technique called "elastography" measures stiffness of tissues and holds potential for providing objective measures for follow-up of treatment of LS in children and adolescents. The team plans to conduct a multicenter study in North America to determine whether elastography ultrasound can show changes in skin stiffness for a period of 9 to 12 months after initiation of treatment for LS. This novel technology may add information to the existing imperfect clinical tools, thus improving the way therapy is offered to patients with LS.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 20 is below the median of 113 across 68 observational studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with diagnosis of LS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma will have a physical examination and elastogrpahy ultrasound at specific timepoints, based on the timeframe for clinical visits. A questionnaire will be administered by the time of each study visit.
Diagnostic Test: Elastography Ultrasound · Other: The Localized Scleroderma Quality of Life Instrument (LoSQI )
The US imaging protocol will include three parts: (i) gray-scale; (ii) color Doppler, and (iii) Shear-wave elastography (SWE)
The questionnaire is a validated disease-specific patient-reported outcome measure that covers different domains (skin sensations, physical functioning, body image and social support, designed for children and adolescents with localized scleroderma
Skin stiffness
Skin stiffness will be assessed using Elastography (SWE) Ultrasound, a sonographic technique that uses mechanical waves to assess tissue elasticity and display it in a quantitative manner. The stiffness of the tissue is directly proportional to its shear wave velocity. SWE will measure interval changes of skin stiffness during treatment at the target lesion and the unaffected contralateral site.
Time frame: Baseline, 3-6m and 9-12m
Lesion activity responsiveness
The LoSCAT (Localized Sclerodema Cutaneous Assessment Tool scores) assesses 18 cutaneous anatomic sites, capturing both disease activity (mLoSSI - Modified Localized Skin Severity Index) and disease damage (LoSDI - Localized Scleroderma Damage Index). Scores for each site are based on the most severe score for each parameter ranging from 0 to 3. A higher score represents a worse outcome.
Time frame: Baseline, 3-6m and 9-12m
Echogenicity scores for dermis and hypodermis
Standard ultrasound protocol. Identifying sonographic changes in the involved body site will be accomplished by comparing both echogenicity and color Doppler signal to a corresponding normal site. The score is determined by summing the absolute value of the individual parameters, with a range from 0 to 15 (maximum echogenicity score of 6, maximum vascularity score of 9). A higher score represents a worse outcome.
Time frame: Baseline, 3-6m and 9-12m
Vascularity scores for dermis and hypodermis
Doppler Ultrasound protocol. Identifying sonographic changes in the involved body site will be accomplished by comparing both echogenicity and color Doppler signal to a corresponding normal site. The score is determined by summing the absolute value of the individual parameters, with a range from 0 to 15 (maximum echogenicity score of 6, maximum vascularity score of 9). A higher score represents a worse outcome.
Time frame: Baseline, 3-6m and 9-12m
Quality of Life
Completiom of the LoSQI (Localized Scleroderma Quality of Life Instrument), a self-reported disease-specific questionnaire to assess the quality of life of patients (children, adolescents and young adults) with localized scleroderma. It consists of 21 items across three theoretical domains: (1) skin sensations, (2) physical functioning and musculoskeletal sequelae, and (3) body image and social support. Scores are based on the most severe score for each parameter ranging from 0 to 3. The questionnaire includes questions that comprise the Pain \& Physical Functioning subscale, and the Body Image \& Social Support subscale. Scores are summoned and converted to a scale, ranging from 41.3 to 71.6 and 43.58 to 68.42, respectively. A higher score represents a worse outcome.
Time frame: Baseline, 3-6m and 9-12m
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Hospital for Sick Children →