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

NCT04809571 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2022-09-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Photoacoustic imaging and Confocal Raman spectroscopy measurement

All subjects will first have their basic history and clinical measurements taken, followed by skin physiology measurements and photoacoustic mesoscopic imaging as well as confocal Raman spectroscopy measurements.

Sponsors & Collaborators

  • National Skin Centre, Singapore

    collaborator OTHER
  • Institute of Bioengineering and Bioimaging (IBB)

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2023-03-24
Completion
2024-01-31

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04809571 on ClinicalTrials.gov