Remote Clinical Skin Trials In A Covid World
Social distancing causes problems for clinical trials where close person to person interaction is needed. Just think of a technician swabbing a volunteer’s face in this Covid 19 world? Yet clinical trials have to continue to test the efficacy and safety of products.
Here we look at Labskin virtual clinical trial (VCT), an innovative method of conducting clinical skin research. It combines our lab grown 3D skin models and our ability to harvest and replicate a volunteers microbiome with proven technologies – online engagement, video, document management, workflow management – to create timely and cost effective trials that are easier and safer for the trial participants.
Labskin’s human skin equivalent platform is an in vitro alternative to using human volunteers and animals in skin testing and is applicable for use in clinical and preclinical evaluations. It consists of human dermal fibroblasts seeded onto a collagen layer, with human keratinocytes layered on top to produce a full-thickness 3-dimensional dermal model with a stratum corneum that can be colonised with skin microbes.
One of our core services for clients is based on an ability to analyse the impact of a product/ingredient or formulation on skin and in the microbiome down to DNA level. We harvest the microbiome/microbiota of a human volunteer and transplant it to lab grown skin. This gives an exact replica of the human volunteers skin microflora. Tests with cosmetic/medical active ingredients or formulations are carried out on those models to assess the effect of any given product on the microbiome. Tests can be carried out on multiple models concurrently or sequentially for in depth investigation.
The Labskin VCT
Labskin scientists create their own microbial mixes of different complexity that mimic a typical skin microbiome tailored to the clients needs. For most testing this is an effective way to understand the effect of products in both the microbiome and the skin itself. However swabbing human volunteers and harvesting each unique microbiome gives a closer approximation to clinical trials and very substantive proof as to the safety and efficacy of the ingredient/product/formulation being tested.
In the pre covid world, clients order tests for specific ingredients/formulations and indicate the type of skin they want tested – age, ethnicity, gender, part of the body etc. Volunteers are identified and brought into labs. They are made aware of the trial protocols, fill in the required questionnaires and then a technician takes a swab where the volunteer’s microbiome is transferred to lab grown skin for the tests to start. Tests are carried out in the lab on the subjects skin clone with regular sequencing to assess impact. If required and in parallel tests can also be carried out on the human subject with regular swabbing and sequencing to see impact of the tests.
Despite Covid 19 these types of trials – ethical, non animal tested and substantive – need to continue. The safety and efficacy of products being used on the skin – whether they are cosmetics, sanitizers or therapeutics – need to be beyond reproach. However with social distancing, processes have to adapt. We can’t put human trialists at risk of infection by having them travel and then having human contact from technicians taking swabs.
The Labskin VCT allows human volunteers to self swab (under video supervision) in their own homes and post their results to our labs for microbiome replication on blank lab grown skin. We’ve also put all the clinical testing protocols, questionnaires and documentation online. And we adapted our store, share and collaborate data platform to make sure all data collected is encrypted and stored securely to meet GDPR guidelines. This last piece is important because the trialist is in control of his/her data. They can ask for access to it. They can request that it be transferred to them. And they can order it deleted, if required.
How it works
Here’s how the remote clinical trial works in practice:
- Collection of the microflora is carried out in the home by the volunteers themselves under strict video/AI supervision/online customer support.
- The volunteers are posted a microbiome collection pack. This pack contains swabs and vessels with proprietary technology that allows swabs and their microflora to be stored and shipped while maintaining the integrity of the microbiome captured.
- The pack has an RFID which brings up a web application where trialists can directly log onto their particular trials.
- Documentation and questionnaires needed are answered and signed online.
- A video screen automatically launches with instructions and AI based guidance to the volunteer on how to take the swab, store it and return it.
- All clinical testing protocols, questionnaires and documentation are made available online.
- Trials happen ethically, efficiently with all protocols being followed and social distancing is maintained.
In the Covid 19 world, this new platform has many benefits:
- Clients get to continue clinical trials with data and analysis that allows faster route to market for new products.
- Clients get clinical trial data precisely compared to data on human tissue models.
- Investigations are carried out under strict laboratory conditions.
- Labskin continues adding value to its clients and keeps helping to extend the breadth and scope of knowledge around the skin microbiome.
- Our partners offer the remote clinical trial as a packaged offering to their clients.
- We build a skin microbiome bank that is used to further train our AI models.
- And it’s safe and convenient for clinical trial participants.