Non-invasive Photoacoustic Mesoscopic Imaging of Clinical Skin Inflammatory Disorders Coupled With Artificial Intelligence-assisted Scoring to Evaluate Disease Prognosis and Associated Metabolic Comorbidities
Trial ID: NCT04809571
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-02-22
Completion date: 2024-01-31
Sponsor: Institute of Bioengineering and Bioimaging (IBB)
Collaborators: National Skin Centre, Singapore
Conditions: Eczema; Psoriasis
Interventions: Photoacoustic imaging and Confocal Raman spectroscopy measurement
Locations: National Skin Centre
Countries: Singapore
Enrollment: 550
Age range: 21 Years - None
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

1. 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
2. Patients with diagnosis of active chronic plaque psoriasis clinically by managing dermatologist based on typical clinical features of psoriasis, with or without diabetes mellitus
3. Healthy controls of age 21 years and above with no known chronic skin conditions, with or without diabetes mellitus
4. Willingness to participate in the study and undergo skin physiological assessments, photoacoustic mesoscopic imaging, and confocal Raman spectroscopy

Exclusion Criteria:

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

Outcomes:
Quantify various photoacoustic imaging based parameter variations characterising psoriasis, eczema, and diabetes mellitus (total blood volume, epidermis thickness, size of vessels); Quantify concentration of natural moisturizing factors in the skin via Raman spectroscopy measurements to characterize psoriasis, eczema, and diabetes mellitus; Novel Eczema Biochemical Index (EBI), based on the biochemical information in skin, formulated using the skin constituents measured from the subjects