Validating Ps-OCT: A new tool to measure skin structure and fibrosis
Research type
Research Study
Full title
Validation of polarisation sensitive optical coherence tomography (Ps-OCT): A new tool to measure skin structure and fibrosis
IRAS ID
300906
Contact name
Andrea Murray
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
Skin thickness and scarring (known in clinical terms as fibrosis) can occur in connective tissue diseases such as systemic sclerosis (SSc, also known as scleroderma) and can have a huge impact on those affected in terms of pain and disability. Objective measures of disease are needed to enable clinical trials of new therapies. Skin changes in SSc are a good indicator of disease progression and severity. It is believed that the changes seen in SSc are similar to those as healthy skin ages with time. Polarisation sensitive optical coherence tomography (Ps-OCT) has shown to be a promising, non-invasive method of assessing skin in SSc and we would like to see how the skin changes in healthy participants in different age groups and compare these changes to a group of patients with SSc. Specifically, we aim to validate the use of Ps-OCT in SSc patients and younger and older healthy participants. Images will be taken from the sun exposed and sun protected side of the forearm of 40 patients with SSc and 60 healthy volunteers (18-30 years or 70 years and above), 80 of whom will return for a second visit. We will compare the results from the Ps-OCT imaging with high frequency ultrasound (also a non-invasive measure of skin involvement), and repeat the imaging over time and between different technicians to see how robust the technique is. The results of this study will contribute to existing early data which suggests Ps-OCT could be a reliable clinical measure of skin thickness that could be used to measure treatment response in in clinical trials.
Summary of Results
This study used a novel technique called polarisation-sensitive optical coherence tomography (PS-OCT), a light-based imaging technique to investigate how skin thickness measurements would compare to those taken with ultrasound. We also compared measures taken (with both techniques) by two observers on same and consecutive days. The study was carried out in a group of healthy controls and patients with systemic sclerosis (SSc). Images were taken at the forearm. The technique was also used to image SSc-related finger lesions (ulcers) to determine whether it may offer a way to measure them and their healing in the future. Forty five controls and 41 patients with SSc patients took part. Four patients had finger lesions. Skin thickness measures taken by the two techniques, PS-OCT and ultrasound, did not match well but for PS-OCT the measurements were reliable (ie measuring the same site twice gives similar skin thickness even on different days or with different people taking the measures. Imaging finger lesions was feasible if patients’ hands could be supported. Lesion size could be measured. The study showed potential for PS-OCT application in skin thickness assessment and to image finger lesions.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0212
Date of REC Opinion
14 Sep 2021
REC opinion
Favourable Opinion