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

NCT04809571 | Unknown

• 1 other identifier: 2020/00079
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief 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

Eczema; Psoriasis

Outcome Measures

Primary Outcomes (3)

• Quantify various photoacoustic imaging based parameter variations characterising psoriasis, eczema, and diabetes mellitus (total blood volume, epidermis thickness, size of vessels)

  The quantified parameters characterizing the skin inflammatory diseases will be aggregated to a novel imaging-based scoring index called novel Eczema Vascular and Structural Index (EVSI, min=0, max= 25, higher scores refer to higher severity of eczema).

  3 years

• Quantify concentration of natural moisturizing factors in the skin via Raman spectroscopy measurements to characterize psoriasis, eczema, and diabetes mellitus

  Raman spectroscopy measures the vibrational modes of the chemical molecules in the skin upon laser excitation, resulting in 'fingerprint' Raman-scattered photons. This allows semi-quantitative estimation of the relative concentration of natural moisturizing factors such as urocanic acid, ceramide and water content in the skin.

  3 years

• Novel Eczema Biochemical Index (EBI), based on the biochemical information in skin, formulated using the skin constituents measured from the subjects

  The EBI scoring system is used to stage disease severity in these subjects. Min=0, max= 80, higher scores refer to higher severity of eczema

  3 years

Study Arms (1)

Photoacoustic imaging and Confocal Raman spectroscopy measurement

EXPERIMENTAL

Other: Photoacoustic imaging and Confocal Raman spectroscopy measurement

Interventions

Photoacoustic imaging and Confocal Raman spectroscopy measurement OTHER

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.

Photoacoustic imaging and Confocal Raman spectroscopy measurement

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a clinical diagnosis of atopic dermatitis based on either the United Kingdom Working Party criteria or the Hanifin and Rajka criteria, age 21 years and above, with or without diabetes mellitus
• Patients with diagnosis of active chronic plaque psoriasis clinically by managing dermatologist based on typical clinical features of psoriasis, with or without diabetes mellitus
• Healthy controls of age 21 years and above with no known chronic skin conditions, with or without diabetes mellitus
• Willingness to participate in the study and undergo skin physiological assessments, photoacoustic mesoscopic imaging, and confocal Raman spectroscopy

You may not qualify if:

• Mentally incompetent, younger than 21 years of age, prisoners, pregnant or breastfeeding women
• Patients unable to provide informed consent
• Any medical condition which makes the candidate an inappropriate subject for study participation, in the investigator's judgment

Sponsors & Collaborators

• Institute of Bioengineering and Bioimaging (IBB): lead
• National Skin Centre, Singapore: collaborator

Study Sites (1)

National Skin Centre

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Eczema; Psoriasis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 22, 2021
• Study Start: February 22, 2021
• Primary Completion: March 24, 2023
• Study Completion: January 31, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

SG (1)