NCT04809571

Non-invasive Photoacoustic Imaging of Skin Inflammatory Disorders With Machine Learning-assisted Scoring

Status unknown NA Last updated 28 September 2022

What this trial tests

NA trial testing Photoacoustic imaging and Confocal Raman spectroscopy measurement in Eczema in 550 participants. Status unknown.

Timeline

22 February 2021

Primary endpoint
24 March 2023

31 January 2024

Quick facts

Lead sponsor	Institute of Bioengineering and Bioimaging (IBB)
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	550
Start date	22 February 2021
Primary completion	24 March 2023
Estimated completion	31 January 2024
Sites	1 location across Singapore

Drugs / interventions tested

• Photoacoustic imaging and Confocal Raman spectroscopy measurement

Conditions studied

• Eczema — all drugs for Eczema →
• Psoriasis — all drugs for Psoriasis →

Sponsor

Institute of Bioengineering and Bioimaging (IBB)

Who can join

21 and older, any sex, with Eczema or Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inflammatory skin disorders are usually assessed by disease scoring system such as Scoring AD (SCORAD)/Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI) for atopic eczema and psoriasis respectively. The current approach to score the severity of these inflammatory skin disorders is through clinical observations and questionnaires. These scores however do not reflect the structural characteristics of the skin such as morphology, vasculature architecture and dermis thickness and are subject to inter and intra-assessor variability. Objective inflammatory diseases indicators through non-invasive imaging techniques have the potential to be an important clinical tool to shed light on its severity in an objective manner. Furthermore, given the abundance of cutaneous vasculature, non-invasive imaging in patients with chronic inflammatory skin conditions allows the investigators to evaluate in detail how co-morbidities of metabolic syndrome, especially type 2 diabetes, further affects the vasculature or the epidermis in the skin. It helps to answer the question of whether a tighter control of the "overlying" skin condition helps in management of the underlying co-morbidities.

Currently, there are many skin imaging modalities available to visualize the morphology and vascular architecture non-invasively, but they are hindered by their penetration depth and lack of contrast. Examples include optical coherence tomography (OCT), high-frequency ultrasound, and Doppler based ultrasound. In this study, these shortcomings will be circumvented through the usage of photoacoustic mesoscopic imaging, a non-invasive, high resolution, intrinsic or contrast-enhanced imaging technique, which can provide functional and metabolic information at greater depths, and an optical fibre-based handheld confocal Raman spectroscopy system with inbuilt data processing algorithms and software, which allows for highly effective and accurate analysis of various skin constituents, such as ceramides, filaggrin, and hydration. These technologies will allow the investigators to study inflammatory and skin barrier markers in, as well as correlations between, psoriasis, eczema, diabetes, and obesity. In addition, by studying the skin before and after therapeutic interventions, this study will aid in understanding the mechanisms of action and efficacy of various interventions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.