IPBIOSS study
Research type
Research Study
Full title
Investigation into Using Polarisation Sensitive Optical Coherence Tomography to Measure Biomarkers in Systemic Sclerosis
IRAS ID
367494
Contact name
Andrea Murray
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Systemic sclerosis (SSc) is a rare autoimmune disease affecting the skin and internal organs. There is currently no cure and treatment options are limited. One reason for this is the lack of reliable biomarkers of disease progression for use in clinical trials. This makes it difficult to assess whether new treatments are effective. This study will examine the use of Polarisation-Sensitive Optical Coherence Tomography (PS-OCT), as a potential biomarker of skin involvement. PS-OCT will be used to explore the following study objectives
1) Antifibrotics: Patients with interstitial lung disease related SSc (ILD-SSc), about to start ‘antifibrotic medication’ to treat their lung disease will undergo PS-OCT to see if changes in skin thickness over time can be detected. This will involve 3 study visits, baseline (before treatment), and 2-follow ups (6&9 months after treatment). Fingers, hands and arms will be scanned, taking approximately 1-hour/visit.
2) Digital Ulcers: Patients with SSc related digital ulcers (DUs) and digital pitting scars (DPS), will undergo PS-OCT to see if healing over time can be detected. This will involve a baseline study visit and follow up visits (every 1-3 months until the DUs/DPS heal). The DUs/DPS will also be imaged using High Frequency Ultrasound (HFUS), taking approximately 1-hour/visit. Participants will also be asked to take digital images of their DUs/DPS (up to 3-times per week, at home, until they heal).
3) Skin Wrinkling: Patients with SSc and healthy controls will undergo PS-OCT to see if to see if differences in skin wrinkling between the two groups can be detected after immersing their hands in warm water for a period of time. Images will also be collected using a thermal imaging camera (TIC). Images will be taken before and after immersion in water, using PS-OCT and TIC. This will involve a single study visit lasting approximately 1-hour.REC name
London - Queen Square Research Ethics Committee
REC reference
26/PR/0258
Date of REC Opinion
25 Mar 2026
REC opinion
Further Information Favourable Opinion