REMOTE CLINICAL SKIN TRIALS
Social distancing causes problems for clinical trials where close person to person interaction is needed. Just think of a technician taking a swab of a volunteer’s face in this Covid 19 world? Yet clinical trials have to continue to test the efficacy and safety of products. But how?
REMOTE CLINICAL TRIALS
Labskin virtual clinical trial (VCT) is an innovative method of conducting clinical skin research. It combines the company’s lab grown 3D skin models, its ability to collect and replicate a volunteer’s microbiome onto these models and proven technologies – online engagement, video, document management, workflow – to create timely and cost effective remote trials – that are easier and safer for the trial participants.
ANCHORED IN SKIN SCIENCE
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.
TRIALS WITHOUT HUMAN VOLUNTEERS
Labskin scientists can 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 on both the microbiome and the skin itself.
TRIALS WITH HUMAN VOLUNTEERS
The microbiome/microbiota of a human volunteer can also be collected and transplanted to lab grown skin. This gives an exact replica of the human volunteers skin microflora – a replicated microbiome. Swabbing human volunteers and collecting each unique microbiome gives a much closer approximation to clinical trials and very substantive proof as to the safety and efficacy of the ingredient/product/formulation being tested.
The platform is fully online and allows participants to self swab and return their results to Labskin labs where the skin with transplanted microbiome is grown/developed for testing.
HOW IT WORKS
- 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 distantly controlled; where all data collected is stored according to the strictest of GDPR guidelines.
DETAILED SEQUENCING DATA
- The trial happens with the human subject regularly swabbing and posting results of their microbiome for sequencing.
- A parallel trial happens on the cloned skin in the lab where swabbing of the clone and sequencing happens.
- Remote real life tests plus controlled tests on clones in the lab plus Sequencing data from both = A comprehensive trial.
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 happen 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
- Labskin partners offer the remote clinical trial as a COTS offering to their clients
- CROs get access to a COTs offering that gives them all of the above