F24-974 Ultrasound shear wave elastography for skin assessment
Research type
Research Study
Full title
Validation of Ultrasound Shear Wave Elastography for Measuring Skin Features and Involvement in Systemic Sclerosis Patients
IRAS ID
351379
Contact name
Francesco Del Galdo
Contact email
Sponsor organisation
Abbvie
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 7 months, 16 days
Research summary
The modified Rodnan Skin Score (mRSS) is currently used for skin assessment in patients with Systemic Sclerosis (SSc) in clinical practice. However, the mRSS has been shown to have marginal performance in discriminating active drug versus placebo in many clinical studies. Taking into consideration the limitations of the mRSS and data from several studies stating ultrasound shear wave elastography (US-SWE) could potentially perform as a less operator-dependent, more reliable, sensitive, and accurate tool to assess skin involvement in patients with SSc. This study will evaluate the reliability of US-SWE in measuring skin involvement in SSc participants and the content validity against collagen quantification in skin biopsies of patients with SSc.
Approximately 60 adult participants with SSc will be enrolled at a single site in UK. No Study drug will be administered. Duration of the study is approximately up to 55 weeks.REC name
West of Scotland REC 4
REC reference
24/WS/0169
Date of REC Opinion
1 Apr 2025
REC opinion
Further Information Favourable Opinion