What is SCARLETRED?
Scarletred is an Austrian digital health scaleup working on revolutionizing dermatology, with headquarters in Vienna, Austria, and an office in Cambridge, Massachusetts, USA. You can read about our history and company information here.
We develop and deliver software products in telemedicine and dermatology. Our main product, Scarletred®Vision, is an internationally-used CE-certified medical device used to document, organize, and analyze skin conditions, ranging from dermatological conditions to wound care and cosmetics. We provide our technology to the pharmaceutical and cosmetic industries for all stages of clinical trials and physicians in the routine clinical setting.
Our mission is to introduce standardization and objectivity in medical data generation, analysis, and measurement.
What is Scarletred®Vision?
Scarletred®Vision is a CE-certified Class 1m medical device. It enables you to develop better skin products and innovative healthcare services at a significantly lower cost. The mobile app and web platform system are ICH-GCP, GDPR, and HIPAA compliant and hold ISO-13845 certification.
Scarletred®Vision objectively and efficiently measures visual changes of the skin. Medical experts can conclude the efficacy of treatments or define the state and progress of an investigated disease based on individual analysis settings.
What are the features of Scarletred®Vision?
Scarletred®Vision includes the following components:
- Mobile App: generation of high-quality images in conformity with data protection regulations and patient anonymity
- QR-Code: information that could be used to identify participants is not scored, and each patient is assigned an anonymized QR-code
- Skin Patches: for the calibration of color, lighting conditions, and size/distance of captured images
- Online Platform: for image data documentation, management, analytical assessment, and quantification of patient data
What is the Scarletred®Vision app?
Our Scarletred®Vision mobile app was developed and tested in clinical trials. It allows implementing a GCP-compliant process in your routine medical applications and all phases of clinical trials.
What is the Scarletred®Vision platform?
It is a dermatological imaging platform for image data documentation, management, analytical assessment, and quantification of patient data.
Can I use the Scarletred®Mobile app without using the Scarletred®Online platform?
Yes, if you only want to take standardized skin images, store your data locally, and do not need the platform features.
What is the Scarletred®Vision skin patch?
The skin patch is the new gold standard for objective skin imaging and is needed to use Scarletred®Vision. It is a biocompatible adhesive film that can be used even for sensitive skin. It is placed next to the investigation area and allows calibrating your images for varying light and distance conditions. The Scarletred®Vision mobile app automatically detects the skin patch. It enables the standardization of images by calibrating the color, lighting conditions, size, and distance of the captured images in a GCP-compliant process.
What is the Scarletred®QR code for?
QR and clinical trial codes enable easy and secure data management, automate data allocation, and optional information exchange. It is an encrypted code unique for every registered user and anonymized for investigated subjects. We ensure that the information which could be used to identify participants is not stored in the system; instead, each individual is assigned an anonymized QR code.
What parameters can be measured with the software?
Our platform can quantify and analyze:
- Erythema (Standard Erythema Value = SEV)
- Any visible change in skin color
What role does skin color and ethnicity play in the analysis?
The software can analyze skin changes in all skin tones based on the individual typology angle (ITA°), which classifies skin types into seven categories. Scarletred®Vision can detect even minor changes in ITA° and enables improved image quality for ITA° assessment compared to other methods currently on the market. This simplifies skin analysis, e.g., of erythema or change in skin tone.
Who can access the uploaded images and data?
The images and data are uploaded to the online platform and meet the highest GDPR standards. Only you and any other authorized individuals assigned to the study have access.
Can additional features be integrated into the system, such as reminders in the App to help patients with the protocol?
SCARLETRED offers flexible SaaS contracts (Software as a Service); therefore, this feature is feasible with our software as it would be a customized solution that needs to be coded by the team.
What is the scientific basis for ScarletredVision?
Since founding SCARLETRED, CEO, Dr. Harald Schnidar has prioritized maintaining a high-quality scientific standard, demonstrating SCARLETRED’s commitment to providing the best possible telehealth solution for skin conditions. SCARLETRED has worked with various medical experts to test and optimize Scarletred®Vision. You will find the complete list of our scientific publications on our website.
How were the objective and quantitative measurement tools scientifically validated?
Scarletred®Vision was developed based on collaborations with many medical experts. In partnership with radio-oncologist Richard Partl, MD, at the Landeskrankenhaus in Graz, Austria, SCARLETRED introduced the standardized erythema value (SEV*) published in the paper 128 Shades of Red (2017), where our technology was brought into a real-life clinical setting. The development of the SEV*, a pseudo-signal map, solved the lack of standardization for quantity-based severity scoring of erythema during radiation-induced skin reactions, and overcame the limitations of image and spectra-based methods.
Artificial intelligence (AI) algorithms have been effectively used for diagnostic and predictive tasks for years, however the use of deep learning neural networks opened the gate for novel results in image processing, classification, segmentation, and object detection. SCARLETRED developed machine and deep learning methods using convolutional neural networks (CNNs) with the potential to support the medical field as a tool for automatic pre-screening of skin toxicity, and decision support in scoring erythema severity. This is described in the paper The Mathematics of Erythema' (2021) about the clinical study validation.
What is the feedback and patient adherence with Scarletred®Vision in clinical trials?
A usability study resulted in a positive outcome, namely a 4-year cooperation and 8 FUP studies in different indications in the USA, Singapore, Germany, and Japan. In terms of remote digital photography, patient adherence is high (measured in daily images and DLQI uploaded). Positive feedback has been given by patients to the investigators/trial coordinators, which highlighted the easy use of the Scarletred®Vision app and the imaging procedure. Generally, patients are more involved and since daily images are documented, treatment efficacy is precisely measurable. Depending on the defined documentation frequency, the exact day of treatment effects can be pinpointed without the need for in-person patient visits.
What are the costs of Scarletred®Vision?
Our service is calculated on an individual basis and depends on size of the trial, patient population site, data volume to be analyzed and the type of required analyses. The exact cost will be agreed under the SaaS contract. An overview of our available plans can be found here. To request a direct quote according to your needs, you can fill out the contact form.
Applications of Scarletred®Vision?
Our product has a wide range of applications and can support the healthcare and medical staff by standardizing skin changes in more than 3000 skin diseases, including skin texture analysis, tissue classification and individual typology angle (ITA) measurement.
It is used in a wide variety of settings, including clinical trials (preclinical to phase IV), routine clinical work, hospital care and remote monitoring of patients. Moreover it can be used as a trial recruiting tool (inclusion criteria) as well as for case studies of treatment follow-up with an approved drug, usability testing, post-marketing study and for digital biomarker development.
Disease applications of Scarletred®Vision:
- Atopic dermatitis
- Radiation dermatitis
- Chronic wounds
- Epidermolysis bullosa
- Hyper- & Hypopigmentation
- Injection site reaction (ISR)
- Hidradenitis suppurativa
- Solar lentigo
- Skin cancer
Is Scarletred®Vision an automated diagnostic tool?
No, the intended use of our product is to document and measure skin changes. In addition, it provides medical professionals with analytical tools to assist in making an objective assessment and diagnosis based on the results with Scarletred®Vision.
Is it used in clinical trials?
Our product is currently used in clinical trials, many of which were hybrid studies. They have ranged from 10 patients to 220 patients across 25 different sites. It complies with all regulatory standards for the usage in clinical studies from Phase I-IV and preclinical trials. Scarletred®Vision offers other various settings, including routine clinical works, hospital care, and remote patient monitoring. The scalability of such a tool is especially valuable in multi-centric clinical trials, allowing the precise monitoring of disease progression.
We are happy to schedule a call with you to discuss your needs.
Which objective measurements would benefit clinical trials?
The PASI score is the standard system and should therefore be included (issued by the investigators). Lesion size, erythema, and the home-based patient-reported outcomes, e.g., DLQI, QoL (all via Scarletred®Vision), can be documented and quantified. If they are correlated with the PASI scores and/or provide more actionable conclusions, they are submitted as study results. If experts document the desquamation and induration score/severity, the texture analysis can be performed on the same lesions for a potential correlation. The experts can consequently use the texture parameter to determine the severity instead of scoring the parameters separately. The software can then detect the lesion automatically. A texture score can be suggested to the doctor through machine learning and AI solutions, saving time and cost resources while keeping the final diagnosis decision in the dermatologist/expert’s hands.
Is it used in hospitals?
Yes, our product is used in hospitals as part of clinical studies and regular medical examinations. We are happy to schedule a call with you to discuss your needs.
Can it be used for remote monitoring?
Yes! Scarletred®Vision is the optimal solution for efficient remote clinical trials and simplifies data collection for subjects at home.
Is the software capable of collecting the patient’s reported symptoms?
Yes, Scarletered ®Vision is capable of collecting patients' reported symptoms of their skin conditions or other non-dermatological symptoms. We can set up questionnaires and electronic patient-reported outcomes (ePRO)to appear at specific study time points after taking the image. These can be configured according to the physician´s requirements and can be used for clinical assessments or at-home remote monitoring. The results are then visualized on the Scareltred®Vision online platform.
How is skin texture measured?
Skin images are generated via the Scarletred®Vision app and transferred to the online platform, where skin texture parameters can then be quantified (the same holds for all other parameters, e.g., erythema, ITA°, etc.). The algorithm behind the texture analysis is based on the established Haralick parameters. It is important to note that translating texture and ITA° (skin tone/phototype) into numbers is not a new system and has been used for years. The innovation here is its integration in our system, its visualization and combination with other analysis parameters (i.e., signal maps), and their automated measurements based on single expert input. On the other hand, the erythema quantification (“Standard Erythema Value'' or SEV) is a patented and validated measurement, superior to the erythema measurement performed using a spectrophotometer.
How do patients use the product?
Each participating patient receives a unique QR code along with their personalized login credentials to the Scarletred®Vision mobile app by the investigation team. This enables the patients to document the progression of their skin disorder via the app as directed by the doctor or clinical trial coordinator.
The patients use the provided Scarletred®Vision biocompatible skin patches which is scanned on the mobile app and allows for the normalization of the images by color and size in compliance with GCP regulations. After taking the skin image, the patient is asked to tag the imaged body part and fill in the related questionnaire, if applicable.
How do health care providers (HCP) or clinicians use the product?
The app is developed and tested in clinical trials and upon request, users can benefit from the 100% controlled remote service in which the latest iPhone models are provided, with the pre-installed Scarletred®Vision app. Healthcare professionals will receive a Scarletred® box containing the created QR-codes and login credentials of each participant along with Scarletred®Vision skin patches.
After the patient uploads an image, it is automatically uploaded to the Scarletred®Vision online platform where the HCP can perform detailed analyses. Scoring, measurement and skin assessment tools can be configured that allow measurement and quantification of the skin area.
How do you ensure that images taken time periods apart can be compared to each other?
The Scarletred®Vision skin patches allows the software to calibrate the images with regards to ambient light conditions, size and distance which is essential for both standardization and comparability of patient images.
What if there is no active internet connection while using the app?
If there is a active internet connection, the uploaded images are immediately uploaded to the Scarletred®Vision online platform. If there is no active internet connection, the images are stored in the Scarletred®Vision mobile app until an internet connection is established and are then uploaded.
Is the product patented?
Yes, Scarletred®Vision is patented worldwide to ensure that our software and skin patch technology are only manufactured by us, thus keeping up the high quality.
What is a medical device ?
According to the Medical Device Directive 93/42/EEC, a ‘medical device’ means any instrument, apparatus, appliance, software, material, or other product, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for:
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease,
- Diagnosis, monitoring, treatment, relief of or compensation for an injury or handicap,
- Investigation, replacement, or modification of the anatomy or a physiological process,
- Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means
Can the product be used internationally?
Yes! The system complies with the European General Data Protection Regulation (GDPR), the US Health Insurance Portability and Accountability Act (HIPAA) and the Act on Protection of Personal Information (APP) in Japan. It is a certified ISO-13485 Quality Management System that is available globally.
Is Scarletred®Vision a medical device?
Yes, it is a CE Class Im Medical Device. It means that our product is compliant with the European General Data Protection Regulation (GDPR), ICH GCP, and HIPAA, so it poses no risk to our patients' data safety or health.
How can I become a Discovery Partner?
Please apply with your skin research project and your specific demand here.
As of 2020 the Discovery Program is only offered to academics and hospital partners.
What is the benefit of applying for the Discovery Program?
Selected Discovery Partners get the full product under significantly reduced fee, for carrying out a joint R&D project, wherein SCARLETRED performs a broad set of analysis services.
I still have some questions. Whom can I ask for an answer?
Please use our contact form to get in touch with us.