Validation of the suction device Nimble for the assessment of skin fibrosis in systemic sclerosis.

ABSTRACT

OBJECTIVES: Skin fibrosis is a main hallmark of systemic sclerosis (SSc). Clinical assessment is done semi-quantitatively using the modified Rodnan skin score (mRSS). Objective measurements for quantifying skin fibrosis could complement the mRSS to achieve higher reproducibility. The aim of this study was to explore the potential of suction measurements to detect structural changes in the skin that are associated with skin fibrosis. METHODS: This clinical trial included 30 SSc patients and 30 healthy volunteers (HC). We validated a novel suction device-the Nimble-to quantify skin stiffness in comparison to the Cutometer using the OMERACT filter. RESULTS: A significant difference (p < 0.05) between the skin stiffness of HC and SSc patient groups was found for each location measured. The correlation between the measurements of forearm skin stiffness and the mRSS values was high for the Nimble (r = 0.82) and moderate for the Cutometer (r = 0.58). A ROC analysis showed good ability for the Nimble to distinguish between SSc patients with and without skin involvement (AUC = 0.82). Both suction devices provided excellent reliability in all measurements on HC and SSc patients and proved face validity and feasibility. CONCLUSION: Suction devices assessing skin stiffness, such as the Nimble, show clear potential to objectively quantify skin fibrosis in SSc patients and might be promising outcome measures complementing established methods such as the mRSS. TRIAL REGISTRATION Clinicaltrials.gov, NCT03644225, Registered 23 August 2018-Retrospectively registered, http//www.clinicaltrials.gov.