FAQ
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 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.
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.
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.
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
- Vitiligo
- Hyper- & Hypopigmentation
- Injection site reaction (ISR)
- Onychomycosis
- Psoriasis
- Rosacea
- Hidradenitis suppurativa
- Solar lentigo
- Skin cancer
Further applications:
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.
How can I upgrade to use the basic and expert tools ?
What do I need to start?
Can I as a dermatologist use the system in the clinical routine?
Yes.
Does the system provide diagnostic features?
No. The intended use of the medical device is to document and measure skin images. Only medical professionals should provide you with a diagnosis and treatment recommendations.
What can I measure with the expert tools of the online platform?
After upgrading to the expert tool, the platform can quantify:
– Erythema
– Pigmentation
– Size
– Patterns
– Scalping
– Any other color change of your skin which can be perceived with your eyes
For which indications can the system be used?
– Acne
– Acute Dermatitis
– Chronic wounds
– Drug allergy
– Epidermolysis bullosa
– Hematoma
– Hyper- and Hypopigmentation
– Onychomycosis
– Psoriasis
– Radiation Dermatitis
– Rosacea
– Skin infections
– Skin patch tests
– Skin prick tests
Who has access to the uploaded images?
The data is encrypted according to highest international data safety standards. Only you and the authorized persons who you assigned to the study have access.
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 basic function of the Scarletred®Online platform?
Depending on your purpose, the web application can be used for single- or multi-centric data collection, exchange and monitoring. You can invite other users, generate new studies and QR codes. Furthermore, your uploaded images are automatically quality-checked by the data integrity tool and pre-analyzed with respect to visual changes.
Is it possible to use the system without the Scarletred®Skin patch?
No.
Why do I need the Scarletred®Skin patch?
It is the new gold standard for objective skin imaging. It is placed next to the investigation area and allows calibrating your images for varying light and distance conditions.
Why do I need the Scarletred®Mobile app?
Our app is the first one which allows to take standardized skin images. Depending on your application, your images can be either stored locally or securely transferred to the Scarletred®Online platform for remote monitoring and optional analysis.
What is the Scarletred®QR code for?
It is an encrypted code which is unique for every registered user and investigated subject and enables easy and secure data management and optional information exchange.
What are the components of SCARLETRED®Vision?
Scarletred®QR code
Scarletred®Mobile app
Scarletred®Skin patch
Scarletred®Online platform
What is the purpose of SCARLETRED®Vision?
It is a revolutionary dermatological software platform for objective quantification and remote assessment of skin changes.
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 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.
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.
I still have some questions. Whom can I ask for an answer?
Please use our contact form to get in touch with us.
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.