EczemaNCT04809571
Non-invasive Photoacoustic Imaging of Skin Inflammatory Disorders With Machine Learning-assisted Scoring
A study testing Photoacoustic imaging and Confocal Raman spectroscopy measurement in people with Eczema and Psoriasis, run by Institute of Bioengineering and Bioimaging (IBB) at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- Photoacoustic imaging and Confocal Raman spectroscopy measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Feb 2021to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Skin Centre
Singapore
Steven TG Thng, 62534455, steventhng@nsc.com.sg
About this study
Official title: 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.
Read the 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.
- Being tested
- Photoacoustic imaging and Confocal Raman spectroscopy measurement
- Medical subject headings
- Eczema, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoacoustic imaging and Confocal Raman spectroscopy measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Photoacoustic imaging and Confocal Raman spectroscopy measurement | Experimental | Not described Receives: Other: Photoacoustic imaging and Confocal Raman spectroscopy measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start22 Feb 2021
- Primary completion24 Mar 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Bioengineering and Bioimaging (IBB)
- Sponsor type
- Other government
- Collaborators
- National Skin Centre, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809571
- Sponsor's protocol ID
- 2020/00079
- Status last verified
- Sep 2022
- First submitted
- 15 Mar 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Photoacoustic Mesoscopic Imaging of Clinical Skin Inflammatory Disorders Coupled With Artificial Intelligence-assisted Scoring to Evaluate Disease Prognosis and Associated Metabolic Comorbidities
- ClinicalTrials.gov ID
- NCT04809571
- Acronym / sponsor ID
- 2020/00079
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Institute of Bioengineering and Bioimaging (IBB)Other government
- Collaborators
- National Skin Centre, Singapore
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 24 Mar 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photoacoustic imaging and Confocal Raman spectroscopy measurement | Experimental | Other: Photoacoustic imaging and Confocal Raman spectroscopy measurement |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoacoustic imaging and Confocal Raman spectroscopy measurementAll 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. | Other | Photoacoustic imaging and Confocal Raman spectroscopy measurement |
Primary outcome
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).
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoacoustic imaging and Confocal Raman spectroscopy measurement in people with Eczema and Psoriasis, run by Institute of Bioengineering and Bioimaging (IBB) at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.