# Quantitative assessment of cutaneous systemic sclerosis.

> **NIH VA I01** · VETERANS HEALTH ADMINISTRATION · 2024 · —

## Abstract

Systemic sclerosis (SSc), or scleroderma, is an autoimmune systemic disease with no cure and the highest
case-specific mortality of all rheumatic diseases. SSc is 3-4 times more prevalent amongst Veterans, partially
due to service-related exposures. Skin is by far the most commonly affected organ, and skin fibrosis, the
hardening and tightening of the skin, is a hallmark feature of SSc. Although skin fibrosis is a key marker of
overall disease severity and a significant cause of morbidity and impaired quality of life, tracking cutaneous
SSc remains an important challenge. The clinical standard for assessing SSc severity, the modified Rodnan
skin score, estimates the degree of skin thickening by pinching, but suffers high interobserver variability,
inability to distinguish treatable active disease from damage, and insufficient sensitivity to change over time.
The lack of reliable measures to track cutaneous disease activity can significantly delay treatment decisions
due to missed opportunities for early intervention to positively alter the disease course.
We propose to address this unmet need for cutaneous biomarkers of SSc with the Myoton, a user-friendly
cellphone-sized device that we have pioneered as a reliable measure of skin sclerosis in graft-versus-host
disease. The Myoton enables precise, reliable, and reproducible measure of mechanical attributes of the skin
through rapid and simultaneous acquisition of five parameters. Our team has validated the Myoton against
conventional clinical assessments, longitudinal therapeutic response, and in tissue models. Importantly, our
existing standardized protocols enable novice Myoton users achieve high intra- and inter-observer reliability in
clinical multicenter studies.
In this proposal, we aim to validate skin mechanical parameters measured by the Myoton a practical cutaneous
biomarker that is linked to the underlying pathology of SSc. We will enroll an observational cohort of 100
Veterans across the full spectrum of cutaneous SSc severity, and 100 matched healthy controls. Over the
course of twelve months, we will acquire Myoton measurements, clinical assessments including the modified
Rodnan skin score and standardized SSc-specific physician- and patient-reported outcome measures, high
frequency ultrasound images, and skin biopsies. First, we will determine the associations between Myoton
measurements and clinical phenotypes of cutaneous SSc. Second, we will determine the quantitative
relationship between Myoton measurements and structural alterations, correlating to both skin thickness
measured by high frequency ultrasound, and tissue pathology markers from histology. Finally, we will assess
how changes in Myoton measurements over time reflect changes in cutaneous SSc severity. We will also
evaluate the ability of early time point Myoton measurements to predict the one-year clinical progression.
In summary, we will validate Myoton’s direct quantification of skin mechanics as a measure of cutane...

## Key facts

- **NIH application ID:** 10804755
- **Project number:** 1I01CX002721-01
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Eric R Tkaczyk
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2024-01-01 → 2027-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10804755

## Citation

> US National Institutes of Health, RePORTER application 10804755, Quantitative assessment of cutaneous systemic sclerosis. (1I01CX002721-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10804755. Licensed CC0.

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