Standardized documentation and scoring of injection site reactions is a crucial part of clinical trials, as local development of skin erythema can reflect on the effectiveness and side effect of an investigational product.
What is injection site reaction?
Injections are widely applied in cases where oral delivery is not possible or would be inefficient, most important for certain biopharmaceuticals, vaccinations, immunotherapeutics or chemotherapy. Consequently, they have to be administered parenterally, such as by means of intravenous, intramuscular, or subcutaneous injection. In this context, injection site reactions are a local skin phenomenon defined as a constellation of symptoms. These are usually mild and go away within one to five days.
Common symptoms of local reactions include:
- Swelling, bruising, burning
In rare cases, local reactions can be significant in size and may extend from joint to joint. These may occur after administration of any vaccine, but are more common after booster doses of diphtheria, tetanus and pertussis. Tracking and measuring vaccination local reactions is thus of utmost importance, especially in the context of COVID-19 where a fast gain of knowledge on the safety and efficacy of novel vaccines is essentially required.
How to document and measure injection site reactions?
Objective and standardized skin imaging: Scarletred®Vision skin imaging technology integrates a clinically validated mobile software core enabling high quality documentation and analysis of an extensive variety of skin conditions. Thereby, injection site reactions can be effectively tracked and measured independent of the individual skin type of each person. In this way, the technology offers an opportunity to improve the efficiency of tracking and measuring local reactions and also allows the patient to visually document erythema and their manifestation remotely from their own home. This is particularly beneficial for biopharma companies and doctors as Scarletred®Vision delivers an easy and time saving method pushing vaccine development quickly forward. On the other hand, in light of the current pandemic situation, patients and doctors can communicate and collect information remotely, ensuring compliance to international regulations, while minimizing the risk of infection.
Real time and secure data transfer: The primary aim in a clinical trial setting is to establish the safety and efficacy of the investigational product via the administration of different doses and the tracking of side effects once it is administered. Scarletred®Vision app together with the platform creates a secure data storage and information flow between patient and professionals. The platform functions as a secure documentation tool providing objective measurement and scoring of local site reactions on the skin surface through the integrated remote data monitoring level and built-in service tools. The real-time based objective visual documentation of skin changes grants enhanced efficiency of monitoring and measurement of local site reactions and a time saving way to track desired or undesired effects of injections on a short and long time frame for daily practice or clinical trials.
Measure, analyze and interpret visual skin changes: Importantly, injection site reactions, such as erythema, can appear differently on different skin types. Thus, in order to objectively score and measure the symptoms and signs of local site reactions, professionals are in need of a technology with not only calibration option, but also tools to allow optimized and standardized measurement, regardless of the skin type of the patient. Such in combination with integrated patient questionnaires deliver a comprehensive understanding of the observed skin reactions.
In response to the current COVID-19 pandemic, biopharma companies all around the world are now working on to develop new therapeutics and vaccines. One of the key success factors of vaccine development, in clinical trials, is the efficient tracking of local injection reactions. In response to the high medical need Scarletred® skin imaging is used to bridge the technology gap between doctors, patients and CROs which impacts in a more efficient and time saving procedure in the development of novel vaccines, biologics or other injectables.