SCARLETRED’s certified medical device tackles rosacea severity analysis by providing professionals a digital solution that allows them to assess and analyze the affected areas in a time-efficient and user-friendly manner.
Rosacea is a chronic skin inflammatory skin condition with a prevalence of approximately 5.46% in the adult population, affecting individuals’ faces, most notably the forehead, nose, cheeks and chin. The condition is characterized by the apparition of erythema (redness) on the aforementioned areas, as well as visible blood vessels and alterations in skin texture with the emergence of inflammatory lesions (papules and pustules).
In the majority of cases, disease severity and classification are determined by the treating doctor’s subjective visual assessment of medically established parameters. The resulting score consequently represents the degree of the expressed phenotypes, such as erythema and flushing.
However, the technological landscape does not provide a practical, precise, and compact solution to assist dermatologists in the diagnosis of disease severity and efficacy assessment of treatment progress. As a consequence, dermatological severity diagnoses by different medical professionals are more prone to subjective variations, a well-known problem which is addressed and solved by SCARLETRED.
SCARLETRED is a digital health company that provides an innovative solution for the documentation, quantitative assessment, and analysis of a broad spectrum of skin conditions ranging from dermatological diseases to drug reactions to injection site reactions.
SCARLETRED has developed a CE certified Class I Medical Device, Scarletred®Vision, that enables doctors and experts to analyze alterations in skin patterns. In addition, the system is ICH-GCP, GDPR, and HIPAA compliant and is a certified ISO-13485 quality management system. The technology is used in clinical trials, in routine clinical work, in the hospital setting as well as in remote monitoring of patients, which, thanks to the software’s user-friendliness, can easily be done from the comfort of their home.
It provides the much-needed tools to document and objectively quantify erythema and skin texture alterations. In order to improve individualized treatment of rosacea patients, quantitatively assessing disease severity and progression as well as response to treatment is of utmost importance.
How does Scarletred®Vision work?
Scarletred®Vision is composed of 3 components:
- The mobile app, which allows the generation of high-quality anonymized images, ensuring patient privacy
- The specially designed skin patch, which allows the software to calibrate the image for light conditions and size/distance
- The online platform: a secure web-based platform that enables doctors and experts to document, assess, and quantify the affected areas
The imaging and analysis procedure consists of 3 steps:
- Place the skin patch on the healthy skin next to the area of interest
- Take an image using the mobile app (the image is then automatically uploaded to the secure online platform)
- The analysis can be performed on the online platform, which offers multiple tools to assist the doctor in their assessment
The technology displays the image in 4 different signal maps, each one highlighting a specific parameter: Standard Erythema Value (SEV*), redness (a*), yellowness (b*), and lightness (L*). Another essential parameter for rosacea assessment is the measurement of skin texture changes. To this purpose, Scarletred®Vision delivers a state-of-the-art tool to quantitatively assess these alterations.
The SEV* map portrays and makes the erythema to stand out more clearly, which, in turn, allows the doctor to easily define the affected area(s) (Images 1.b and 2.b). Consequently, the measurement and analysis tools enable the precise selection of the area(s) of interest (AOI). Once selected, the software produces the corresponding data which can directly be visualized on the platform using the analytical tools (Figure 1).
The software uses clinically validated methods that analyze skin texture and delivers quantitative data describing skin smoothness/roughness.
The analyzed image is displayed in signal enhanced color maps visually augmenting the result (Images 1.c and 2.c).
Before Treatment: 1a. Calibrated Original, 1b. SEV* signal intensity map: augmented erythema, 1c. Texture
After Treatment: 2a. Calibrated Original, 2b. SEV* signal intensity map: augmented erythema, 2c. Texture
The rosacea patient’s affected left cheek was imaged using Scarletred®Vision and the Scarletred®Skin Patch at 2 different time points during the treatment. The red circle is the tool used to select and define the affected area of interest where the erythema needs to be quantified. Images 1a and 2a: Original calibrated images taken with the Scarletred®Mobile App. Images 1b and 2b: The same patient images are displayed here in the Standard Erythema Value (SEV*) signal map: the software’s algorithm takes into account the redness of the skin and lightness in order to produce an erythema value: the patient’s healthy skin is used as reference, manually defined using the black circle. Images 1c and 2c: The images are displayed in an augmented signal map to make the texture changes more visually perceivable.
Figure 1: Table: Summarized erythema (SEV*) values for the different time points. Left Panel: The data resulting from the selection tool (Images 1 and 2) can be plotted directly on the Scarletred®Online Platform. The red line represents the cheek erythema values and the black line represents the reference values (skin unaffected by rosacea). Right panel: The graph can be customized by the user to show the relevant parameters either for all or for specific time points.
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 technology offers digital documentation and analytical tools that have been proven, both in the clinical and home-based settings, to increase data quality, to enable doctors to quantify visual parameters, to improve patient treatment regimen and patient compliance, to save doctors time, and to generate analyses that are not obtainable with other technologies in the field.
For more information, we strongly encourage you to get in touch with us so that we can discuss how to best tailor our solution to fit your needs: firstname.lastname@example.org.