Elastography Ultrasound in Localized Scleroderma (Morphea) Study

The Hospital for Sick Children

Status: Invitation-only

Conditions: Scleroderma

Treatments: Other: The Localized Scleroderma Quality of Life Instrument (LoSQI ); Diagnostic Test: Elastography Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06847750

1000078198

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Boys and girls 0-18 years of age at the time of disease onset with a new or existing diagnosis of localized scleroderma (LS) confirmed by a pediatric rheumatologist or dermatologist.
• Presents with one active or inactive lesion, using the contralateral site for comparison at each visit, as long as the same lesion is evaluated at each time point. OR Presents with more than one lesion as far as both lesions are active or inactive.
• Able to cooperate with clinical and US evaluation, and the parent or guardian is able to fill out interim patient history form.

Exclusion criteria

• Patients with other co-morbidities (e.g. systemic sclerosis, juvenile idiopathic arthritis, other systemic diseases).
• Patients who present with one active and one inactive lesion.
• Patients with lesions located in the face or head.

Trial design

20 participants in 1 patient group

Elastography group

Description:

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.

Treatment:

Diagnostic Test: Elastography Ultrasound

Other: The Localized Scleroderma Quality of Life Instrument (LoSQI )