SCARLETRED’s certified medical device provides medical professionals a novel digital solution that allows them to assess and analyze the individuals’ affected areas in an accurate, time-efficient and user-friendly manner.
Psoriasis is a chronic inflammatory disease of the skin associated with red, raised plaques and scaly skin. Psoriasis is a global problem affecting approximately 2-3% of the total population (National Psoriasis Foundation, 2020).
In a clinical setting, having a reliable, accurate and comparable method for the assessment of disease severity has utmost importance. Even though there have been more measurement tools developed using a combination of scoring methods to address limitations in psoriasis assessment, such as reliability, there is still space for improvement. Digital technology allows the enhancement of traditional scoring methods with potential to improve health care services, granting objective disease monitoring and measurement.
SCARLETRED is a digital health company providing a novel solution 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 developed by SCARLETRED. 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 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® 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 medical professionals.
Step 4 (Optional): Electronic patient reported outcome (ePRO) 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 subject´s image.
The image, taken with the mobile app, is automatically uploaded to the online platform where it can be visualized (Figure 2). The technology displays the image in four different signal maps, each one highlighting a specific parameter: Standard Erythema Value (SEV*), redness (a*), yellowness (b*), and lightness (L*). This allows medical professionals to objectively assess, quantify and monitor the severity and manifestation of psoriasis over time.
The Psoriasis Area and Severity Index (PASI) scoring tool is used for the measurement of psoriasis severity in the four body zones- head/neck, upper limbs, trunk, and lower limbs. For each location, a score is calculated based on the severity and surface area involvement. The severity score consists of three attributes, erythema (redness), induration (thickness), and desquamation (scaling) rated on a scale from 0 (none) to 4 (very severe). The surface area involvement is rated on a scale from 0 to 6. Each of the body location scores is calculated by multiplying the severity sum score and the weighted surface area score (Figure 2).
In addition, the previously filled ePROs by patients are documented and can be viewed on the online platform, providing further insights into the patients' Quality of Life (QOL), vital signs, and enabling the real-time tracking of symptoms.
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.
Don’t be a stranger! Get in touch with our Team so that we can discuss how to best tailor our solution to fit your needs: email@example.com.