VivoScene

July 2021 Issue

Innovaderm is one of the leading Clinical Research Organizations (CRO) and research sites in Dermatology. It has an international reputation for the quality of its studies in atopic dermatitis, psoriasis and acne vulgaris.

Innovaderm recently acquired a VivoSight OCT system and went through the first phase of clinical launch. Founder and CEO Robert Bissonnette, MD states, “we need to be on the forefront of providing excellent services to our clients. The subclinical visualization and quantification capabilities of VivoSight are welcome additions to accelerate our research and clinical development work.”

The Innovaderm research site just made first of the ‘Top 10 Research Sites’ with the most completed clinical trials in atopic dermatitis as per TrialHub. The CRO unit has also been recognized for the quality of its work and has been awarded a 2021 CRO leadership award.

If you want to collaborate with Innovaderm on studies managed in North America, Europe and Asia-Pacific, please click here.

Robert Bissonnette, MD & CEO of Innovaderm. VivoSight OCT
Robert Bissonnette, MD & CEO of Innovaderm.

Michelson Diagnostics Ltd. (MDL), the UK manufacturer of the VivoSight OCT skin imaging system, collaborates with AI specialist Manchester Imaging Ltd. to develop AI-enhanced BCC detection capabilities.

Manchester Imaging VivoSight OCT

Artificial Intelligence (AI) applies the latest developments in machine learning, computer vision, neural networks and advanced algorithms to provide practical assistance to clinicians in their use of OCT imaging of BCC. AI could help by rapidly picking out and quantifying ‘biomarkers’ for BCC in the VivoSight images in order to streamline workflow and further optimize sensitivity and specificity.

Our collaborator Manchester Imaging Ltd. already has an AI product on the market for dentistry for use on difficult to interpret radiographic images of X-ray bitewings for enamel-only proximal caries, and has shown that dentists achieved a 76% detection rate when aided by their AI software, compared to only 44% without AI (Figs. 1a, b).

Fig. 1a: AI software significantly improves the detection rate of enamel-only proximal caries when bitewing radiographs are examined.
Fig. 1b: Sensitivity of detecting enamel-only proximal caries without (yellow) or with (blue) AI enhanced software.

Jon Holmes, CEO of MDL, remarks, “our goal is to use OCT to minimize interventional management of low risk BCC, for both physician and patient. I believe AI has real potential to deliver benefits towards this goal. Easier and earlier AI-enhanced OCT BCC detection, mapping and treatment monitoring dovetails very well with emerging non-invasive, more effective treatment options for low risk BCC lesions, by providing patients and physicians with confidence that the BCC is accurately and effectively treated through to clearance of the tumor.” 

Jon Holmes continues, “our work with Manchester Imaging Ltd. is proceeding at pace, and we expect to have a working prototype very soon (Figs. 2a, b); we are now establishing an AI-VivoSight OCT Clinical Working Group with leading dermatologists experienced in VivoSight OCT use and BCC management to help evaluate it, and to provide insights and feedback on how the AI-enhanced OCT tool will be most useful in practical clinical use.” 

Jon Holmes, CEO of Michelson Diagnostics Ltd.
Fig. 2a: AI-aided marking of tissue suspicious for BCC in 2D frame view.
Fig. 2b: Early results of AI-enhanced 3D visualization.

MDL CEO Jon Holmes concludes “this project, targeting BCC, is just the beginning for AI and VivoSight OCT. VivoSight has a broad range of imaging and clinical applications (see VivoSight Publications Register) and we expect that AI will eventually provide support for many other clinical questions addressable with OCT imaging; we welcome ideas and suggestions from anyone!”.

As mentioned in our previous newsletter, in close cooperation with the University Hospital of Augsburg, Germany and Michelson Diagnostics, our strategic partner DermoScan GmbH has developed a multi-session online course: OCT in Practice.

The modular course is aimed at VivoSight newcomers and experienced users alike. Presently, 12 main topics are being covered (overview >> here) focusing on when and how to ideally use OCT. You will learn how to assess the most common skin tumors and pathology based on typical visual criteria and receive helpful tips and explanations on OCT image interpretation (Figs. 3a, b). We also present rare or experimental OCT applications. Finally, test your knowledge in a quiz on OCT images of BCCs!

Renowned OCT expert Julia Welzel, MD is a co-author of the “OCT in Practice” course.
Renowned OCT expert Julia Welzel, MD is a co-author of the “OCT in Practice” course.
Fig. 3a: Individual topics are covered in easy to follow, extensive slide presentations.
Fig. 3b: Topics are further augmented in video tutorials.

“As I am working in a busy practice, it was very practical to attend the course at my own schedule. The learning modules are logically structured, from beginner to advanced level, and they are effective. In a short while I was able to utilize VivoSight for my clinical work with patients, but will also become more experienced over time to get the most out of the system.”

Henrik Mohme, MD, Dermatologist, Porta Westfalica, Germany

The online course is available for a one-time fee of 490 Euros. Interested parties should contact our strategic partner DermoScan at oct@dermoscan.de and will be provided with a quotation and other details.

Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure [1]:

Olsen et al. demonstrate the feasibility of dynamic-OCT to evaluate epidermal thickness and blood vessel depth for the assessment of photoaging.

Photoaging predominantly occurs in the face, neck and hands due to UVA and UVB irradiation. Histological studies indicate thinning of the epidermis and elastosis. The group found a significant age-related decrease of epidermal thickness and blood vessel depth as well as a seasonal effect on both epidermal thickness and blood vessel depth.

Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery [2]:

Another stellar paper from Denmark! Fuchs et al. use both VivoSight OCT and RCM to describe subclinical acne treatment effects with in-vivo imaging.

Recent reports on the high correlation between clinical acne severity and optical imaging features substantiated the utility of real-time, noninvasive imaging to obtain quantifiable data on micromorphology and gold microparticle distribution.

The authors conclude that the implementation of OCT and RCM in clinical and research settings permits the assessment of early sub-clinical treatment response and furthers the understanding of effective strategies to enhance transfollicular drug delivery.

Microneedles for gene and drug delivery in skin cancer therapy [3]:

Excellent review paper from Zhi et al. covers two main specialties of VivoSight OCT: imaging of skin cancer and Microneedle patch insertion behavior. 

Microneedles (MNs) are an excellent minimally invasive delivery method, as they can bypass the stratum corneum and enter the skin microcirculation to achieve drug and gene delivery. The review summarizes the latest developments in MNs for gene and/or drug delivery, with a focus on their performances as effective MNs for skin cancer treatment. (Note also the many educational assets on our website’s blog page about the use of VivoSight OCT to optimize microneedle performance.)

Comparison Screen Feature

An excellent way to observe morphologic and angiographic changes is the comparison screen feature. Note the clear difference in image and metrics after exposing skin to an irritant. The changes in the lower image take place within minutes.

The comparison screen feature makes it easier to detect and quantify subclinical changes, as such accelerating your research and clinical development work.

VivoSight OCT can effectively characterize the insertion behavior of Microneedles Array Patches (MAPs), and collaborations between industry and academia are being established.

Michigan based TSRL Inc., a preclinical pharmaceutical accelerator company, announced that it has entered into a licensing agreement with The Queen’s University of Belfast for the exclusive use of their patented hydrogel microneedle (MN) technology for the development of a MN patch for treatment of the flu. Future uses of the platform with other therapeutics and vaccines can be optioned (Press Release here).

VivoSight OCT is heavily utilized by Queen’s University’s Prof. Ryan Donnelly and his group to optimize Microneedle Array Patch (MAP) performance. See a number of educational blogs here

Microneedle Array Patch (MAP) unevenly penetrating skin surface (top). Time course of dissolving needles (bottom).
Microneedle Array Patch (MAP) unevenly penetrating skin surface (top). Time course of dissolving needles (bottom).

Uninterruptible Power Supply (UPS) and New Higher Resolution Camera

VivoSight systems shipped after June 2021 will contain an internal UPS (Uninterruptible Power Supply) that mitigates against power interruptions for up to 70 seconds. This will also be available as a field upgrade to older units.

In addition, new VivoSight units will be fitted with a new, higher resolution probe camera, to further aid accurate probe placement. Older units can also be upgraded at MDL’s factory.

Standard probe camera image (left) and new probe camera image (right).
Standard probe camera image (left) and new probe camera image (right).

Dr. Barry DiBernardo, MD is a board-certified plastic surgeon and the medical director of New Jersey Plastic Surgery in Montclair. In practice for more than 30 years, he also undertakes a high amount of clinical research.

“In our practice we participate in clinical research with skin tightening technologies to improve skin laxity and wrinkle appearance. With VivoSight we can visualize and quantify skin surface roughness which gives us an objective metric for measuring treatment impact and helps us focus in on the most effective therapies for each patient.

An example of how we use VivoSight is represented in the images below where we are using the VivoSight Skin Roughness Measure to quantify the improvement in the surface texture of the skin in response to treatment.

Barry DiBernardo, MD

In addition to this type of application we are also using VivoSight to:

  • Monitor the treatment of scars
  • Evaluate skin conditions such as acne to help determine depth
  • Identify how topicals affect skin texture and vascular density
  • Image micro-coring and needling to see hole closure in clinical trials
  • Monitor changes in vascularity over time for certain treatments”.

Dr. DiBernardo concludes, “finally, VivoSight greatly complements my Canfield and other imaging systems. They all have strengths in different areas and with VivoSight I can see surface and subsurface pathology, structural and vascular morphology, to more than a millimeter deep. This allows me to assess the patient’s skin more thoroughly, document treatment results, but also conduct more information based patient consultations”.

Research work at New Jersey Plastic Surgery: VivoSight objectively measures reduction in skin surface roughness after skin tightening procedures.

References

1. Olsen, J., Gaetti, G., Grandahl, K. et al. Optical coherence tomography quantifying photo aging: skin microvasculature depth, epidermal thickness and UV exposure. Arch Dermatol Res (2021). https://doi.org/10.1007/s00403-021-02245-8

2. Fuchs CSK, Ortner VK, Hansen FS, Philipsen PA, Haedersdal M. Subclinical effects of adapalene-benzoyl peroxide: a prospective in vivo imaging study on acne micromorphology and transfollicular delivery. J Eur Acad Dermatol Venereol. 2021 Jun;35(6):1377-1385. doi: 10.1111/jdv.17140. Epub 2021 Mar 5. PMID: 33508886. https://pubmed.ncbi.nlm.nih.gov/33508886/

3. Defu Zhi, Ting Yang, Tingyu Zhang, Mei Yang, Shubiao Zhang, Ryan F. Donnelly, Microneedles for gene and drug delivery in skin cancer therapy, Journal of Controlled Release, Volume 335, 2021, Pages 158-177, https://doi.org/10.1016/j.jconrel.2021.05.009