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

September 27, 2022 updated by: Institute of Bioengineering and Bioimaging (IBB)

Non-invasive Photoacoustic Mesoscopic Imaging of Clinical Skin Inflammatory Disorders Coupled With Artificial Intelligence-assisted Scoring to Evaluate Disease Prognosis and Associated Metabolic Comorbidities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Inflammatory skin diseases are increasingly common in various industrialized western societies. In 2015, eczema or dermatitis, the most common inflammatory skin disease, is estimated to have affected 245 million people worldwide. In fact, the biggest percentage of cases seen in National Skin Centre (NSC), Singapore is for dermatitis (34.1%) while other inflammatory skin diseases such as contact dermatitis and psoriasis account for 4.7% and 3.3% of the cases respectively. Inflammatory skin diseases can cause remodeling of the vasculature. This vascular remodeling is brought about by the imbalance between pro- and anti-angiogenic mediators under conditions of chronic inflammation, resulting in either vessel growth or recession. Vascular remodeling of affected skin usually display vascular enlargement during inflammation. In psoriasis, for example, the skin capillaries expand and become tortuous, making the lesions appear red due to the thinned epithelium.

Emerging evidence reports that chronic inflammatory skin diseases are closely related to systemic complications such as atherosclerosis, type 2 diabetes or metabolic syndrome due to systemic inflammation. One possible theory linking cutaneous and systemic vascular diseases is from the release of products such as inflammatory cytokines produced in affected skin lesions into the systemic circulation, resulting in the increased risk of inflammation in other organs or tissues. It was reported that individuals with Atopic Dermatitis (AD) in the adult US population tend to have a self-reported history of hypertension and adult-onset diabetes even with control of body mass index and other comorbidities. An analysis of different studies indicated that both individuals from Asia and North America with pediatric and adult-onset of AD have a higher chance of being overweight, which can lead to other metabolic diseases. It was also reported that there is an increased number of inflammatory cells around vessels seen in histopathology biopsies of the human forearm skin for diabetic patients compared to non-diabetic populations. The density of vascular network also tended to be higher in diabetic patients in the forearms compared to non-diabetic subjects. However, no difference in vascular networks were observed between subjects with Type 1 and Type 2 diabetes. The mechanism to explain the increased vessel density in diabetic subjects is not known, though inflammation plays a role due to the presence of inflammatory cells. Since inflammatory skin diseases are systemic disorders due to the co-morbidities, it would shed light on the understanding of these diseases and their linkages to metabolic disease such as diabetes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Photoacoustic imaging and Confocal Raman spectroscopy measurement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantify various photoacoustic imaging based parameter variations characterising psoriasis, eczema, and diabetes mellitus (total blood volume, epidermis thickness, size of vessels)
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Bioengineering and Bioimaging (IBB)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Skin Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/00079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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