Clinical trial NCT06847750: Elastography Ultrasound in Localized Scleroderma (Morphea) Study
Official title: Elastography Ultrasound in Localized Scleroderma (Morphea): a Prospective, Longitudinal, Multicentric Pilot Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Scleroderma
Keywords: Elastography ultrasound
Scleroderma
Quality of Life
Pediatric
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Childhood Arthritis and Rheumatology Research Alliance
name: Joseph Sanzari Children's Hospital
name: University of Pittsburgh
First posted: 2025-02-26
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of LS

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Skin stiffness
timeFrame: Baseline, 3-6m and 9-12m
Secondary outcomes:
measure: Lesion activity responsiveness
timeFrame: Baseline, 3-6m and 9-12m
measure: Echogenicity scores for dermis and hypodermis
timeFrame: Baseline, 3-6m and 9-12m
measure: Vascularity scores for dermis and hypodermis
timeFrame: Baseline, 3-6m and 9-12m
measure: Quality of Life
timeFrame: Baseline, 3-6m and 9-12m
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: