SCARLETRED’s certified medical device provides medical professionals a novel digital solution that allows them to assess and analyze individuals’ affected areas in an effective, time-efficient, and user-friendly manner.
Atopic dermatitis (AD), also known as atopic eczema, is a chronic relapsing inflammatory dermatological condition affecting approximately 2.4% of the total population (Urban et al., 2021). Signs and symptoms vary widely from person to person, but they commonly include dry, itching, thickened, scaly, and sensitive skin.
Assessment of disease activity is key in clinical management and monitoring of patients with AD. This applies to professionals in their daily routine as well as during clinical trials. To this purpose, providing dermatologists with an easy-to-manage mobile data management system accessible from any computer would empower dermatologists to establish in-clinic standardized documentation and analysis methods for AD patients. Additionally, the scalability of such a digital tool, especially of value in multi-centric clinical trials, allows to precisely follow patient treatment progression and thus the efficacy of the investigational product consistently throughout the entire study.
In this context, SCARLETRED, an Austrian digital health company, has developed a novel solution, Scarletred®Vision, for the standardized documentation, assessment, quantification, and analysis of conditions ranging from dermatological indications to drug reactions to fungal conditions.
Scarletred®Vision is a CE certified Class I Medical Device: the system is ICH-GCP, GDPR- and HIPAA-compliant and is a certified ISO-13485 Quality Management System. It is used in a wide variety of settings, including clinical trials (preclinical to phase IV), routine clinical work, hospital care as well as remote monitoring of patients. Scarletred®Vision’s scalability allows doctors to easily empower their subjects to participate and provide valuable data remotely, from the comfort of their home.
How does Scarletred®Vision work?
Scarletred®Vision consists of the following components:
Mobile App: generation of high-quality images in conformity with data protection regulations and patient anonymity
Skin Patches: calibration of the captured images for color, lighting conditions, and size
Online Platform: documentation, assessment, and quantification of patient data
Scarletred®Vision Mobile App: Imaging & ePRO
Step 1: Place the Skin Patch on the healthy skin next to the area of interest.
Step 2: Take an image using the Mobile App, which is then automatically uploaded to the secure online platform.
Step 3: The analysis can be performed on the Online Platform, which offers multiple tools to assist the medical professionals.
Step 4 (Optional): Electronic Patient Reported Outcomes (ePROs) and questionnaires can be customized and configured to appear after the image has been taken (Figure 1). The answers and the resulting score are documented centrally on the platform together with the with the corresponding AD image.
Scarletred®Vision Online Platform: Documentation
Images are automatically uploaded to the online platform (Figure 3), where it can be visualized and analyzed. One of Scarletred®Vision’s most iconic signal maps is the Standard Erythema Value (SEV*): this augmented visualization technology allows for erythema to stand out more clearly while taking into account the individual's native skin color, thereby enabling the dermatologist to make a more objective visual assessment while facilitating the quantification of the lesion (Figure 2).
Scarletred®Vision Online Platform: Analysis
The analysis tools on the online platform allow users to visualize and graph the selected values for different time points. The analysis can be customized to show the relevant parameters (area, SEV*, L* or b*) for all or for selected time points. By monitoring patient treatment progression, through the quantification of specific parameters can contribute to the evaluation of the efficacy of the applied treatment (Figure 4).
Scarletred®Vision’s innovative approach to creating digital solutions is the first of its kind. Its modular framework makes it applicable to all skin conditions (dermatological diseases, injection sites, drug reactions, allergic reactions, cosmeceuticals and many more). The certified Medical Device offers digital documentation and analytical tools that have been proven, both in the clinical and home-based settings, to increase data quality, enable doctors to quantify visual parameters, to improve patient treatment regimen and patient compliance, save doctors time, and generate analyses that are not obtainable with other technologies in the field.
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