Clinical trial NCT05672992: Longitudinal Spatial Frequency Domain Imaging Study
Official title: Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Scleroderma
Keywords: Spatial frequency domain imaging (SFDI)
modified Rodnan skin score (mRSS)
Skin biopsy
Skin fibrosis
Scleroderma skin patient reported outcome (SSPRO)
Durometry
Ultrasound
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Scleroderma Clinical Trials Consortium (SCTC)
name: Fibrosis ARC: Connecting Tissues and Investigators (FCTI ARC)
First posted: 2023-01-05
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS).

Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients.

This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

Detailed description: The overall objective of this study is to determine if a light emitting diode (LED) -based SFDI instrument can be used to detect changes in skin thickness over time in SSc patients.

Number of subjects:

60 patients with scleroderma and 32 control subjects without scleroderma

Study procedures:

All subjects will have 6 areas of the body, right and left fingers, hands, and forearms, measured with an LED-based SFDI instrument every 3 months for the first 12 months and then every 6 months through 36 months. The right and left upper arms of subjects may be measured with the SFDI instrument if subjects are able to comfortably extend their arms.

All subjects will have the option to have blood collected for serum at baseline, 12 months, 24 months, and 36 months to investigate serum biomarkers of fibrosis.

An optional skin biopsy will be collected from all subjects at baseline, 12 months, 24 months, and 36 months to evaluate histopathological skin changes. Skin biopsies will not be collected from pregnant or lactating subjects, from subjects with a history of an allergic reaction to a local anesthetic, or from subjects who are deemed by the study doctor to be at high risk of small tissue calcification.

Scleroderma subjects will be asked to complete the SSPRO questionnaire at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

Scleroderma subjects will have a mRSS performed at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

All subjects will have durometry and ultrasound performed on the right and left forearms at baseline and every 3 months for the first 12 months and then every 6 months through 36 months.

Secondary Objectives:

* Assess how SFDI measurements correlate with other clinical measurements of skin thickness such as durometry, ultrasound, and mRSS
* Assess how SFDI measurements correlate with clinical biochemical and histopathological assessments of skin changes in SSc.

Eligibility criteria: Inclusion Criteria:

Participants must meet at least one of the following:

* Have SSc as defined by the American College of Rheumatology (SSc subjects only)
* Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only)
* Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results)

Exclusion Criteria:

* Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
* Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
* Presence of other co-morbid illnesses with an estimated median life expectancy \< 5 years.

Primary outcomes:
measure: Baseline SFDI measurements of skin thickness
timeFrame: baseline
measure: 6 months SFDI measurements of skin thickness
timeFrame: 6 months
measure: 12 months SFDI measurements of skin thickness
timeFrame: 12 months
measure: 18 months SFDI measurements of skin thickness
timeFrame: 18 months
measure: 24 months SFDI measurements of skin thickness
timeFrame: 24 months
measure: 30 months SFDI measurements of skin thickness
timeFrame: 30 months
measure: 36 months SFDI measurements of skin thickness
timeFrame: 36 months
Secondary outcomes:
measure: Serum fibrosis biomarkers, Chemokines that promote fibrosis
timeFrame: baseline and every 12 months up to 36 months
measure: Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration
timeFrame: baseline and every 12 months up to 36 months
measure: Serum fibrosis biomarkers, Matricellular proteins
timeFrame: baseline and every 12 months up to 36 months
measure: histopathological assessments of skin collagen content
timeFrame: baseline and every 12 months up to 36 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shapiro Outpatient Rheumatology Clinic at Boston Medical Center
state: Massachusetts
Study officials:
affiliation: BU Chobanian & Advesian School of Medicine
name: Andreea Bujor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: