[R01] Assessing spatial frequency domain imaging as an objective quantification of longitudinal skin changes in scleroderma
Ente: National Institute of Arthritis and Musculoskeletal and Skin Diseases
Scadenza: 2029-03-31
Importo max: 165.034 EUR
Paese: US
Descrizione
PROJECT SUMMARY/ABSTRACT
Systemic sclerosis (SSc) is an autoimmune connective tissue disease, with a 10-year mortality of 40%, the
highest of all autoimmune diseases. Painful, itchy skin tightening is an early feature, and can have a major impact
on quality of life and daily living. Clinically, quantification of skin fibrosis in SSc is performed using the modified
Rodnan skin score (mRSS), which involves pinching of the skin in several body areas. mRSS is subjective, has
high inter-rater variability, and may not be sensitive enough to detect small but clinically meaningful changes.
Clinical trials using mRSS as an outcome measure have failed, leading to a lack of skin-directed FDA-approved
therapies. The overall goal of our research is to solve this unmet clinical need, by delivering an outcome measure
for monitoring SSc skin disease that is both objective, sensitive, and reliable. Spatial frequency domain imaging
(SFDI) is a low cost, objective and noninvasive method that can rapidly measure a large tissue area (> 10 x 10
cm) with penetration depths of 1-5 mm. Results from our prior study suggest that SFDI could accurately quantify
skin changes in SSc, and can even detect sub-clinical skin changes, with an inter-observer variability that
outperforms that of mRSS. Preliminary results show strong correlation between longitudinal changes in SFDI
with changes in mRSS scores in individual patients. The specific aims of this proposal will prospectively evaluate
the ability of SFDI in tracking disease change over time in individual SSc patients. Over a 12-month period, we
will track changes in disease activity by measuring SFDI at specific time points. We will then compare its
performance with established clinical skin outcome measures and PROs in Aim 1, and with other noninvasive
skin metrics and histology disease markers in Aim 2. Successful completion of these aims will help further
validate SFDI as an objective and sensitive skin outcome measure both for disease management and for future
use in SSc clinical trials.
Istituzione: BOSTON UNIVERSITY MEDICAL CAMPUS
PI: Andreea Monica Bujor, Darren Michael Roblyer
Progetto: 5R01AR085317-02
Settori: National Institute of Arthritis and Musculoskeletal and Skin Diseases
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