Post — 10 Min Read

Product Testing in a Post-Pandemic World

Labskin has built a remote clinical trial platform that allows trials to happen ethically and efficiently with protocols being followed and distantly controlled.

Labskin has built a remote clinical trial platform that allows trials to happen ethically and efficiently with protocols being followed and distantly controlled; where all data collected is stored according to the strictest of GDPR guidelines; and critically, swabbing can be done under supervision in the trialists’ own home so no in-person contact is needed.

The spread of SARS-COV-2 has seen so many changes happen throughout the world. How business is done has changed drastically. Face-to-face meetings, business travel and large face-to-face conferences are currently unworkable due to restrictions around the world.

Physical and face-to-face interactions are part and parcel of human connections, learning new ways to carry out our day-to-day lives will require us all to be imaginative, innovative, and open to change. Adapting to the new normal will be complicated for business.

For the cosmetic and skincare industries, social distancing is creating many new challenges to be overcome. From the consumer end of beauty consultations or dermatology appointments, right back to research and development in human and clinical trials or collaborating with academic institutes and partnering with other companies. For some challenges, the solutions are simple – PPE used regularly, shorter appointments and online meetings and conferences will for the most part solve the interaction aspects. However, far bigger challenges exist at the research and development level. Labskin has moved into this space and has a solution.

The Background

Labskin AI technology is based on the work of Labskin’s sister company Rinocloud. Before partnering with Labskin under the Integumen PLC umbrella, Rinocloud, a data management and analysis company, was based in the University of Cambridge, UK.

The same AI and machine learning models that are used in the Labskin AI platform were used successfully in the past in complex projects to identify, in real-time, contaminants in water, pathogens in blood and mastitis in cow’s milk.

Labskin AI is used to de-risk pre-clinical research and clinical trials and has virtualized the Labskin platform to give secure online access to clients and research partners alike. The Labskin AI platform is already proven to provide a “fast-fail, quick-win” process, saving both time and money.

Labskin’s Solution – Remote Clinical Trials

Months before the beginning of the Covid-19 pandemic, Labskin had begun work on the Remote Clinical Trial aspect of the Labskin Virtual Labs, based on fourteen years’ work and experience.

This has also extended to isolating the whole skin microbiome for a chosen skin site and transplanting those isolates into replicated Labskin, creating a skin model that closely resembles the biological properties of the human skin.

Labskin’s partners and clients have found this approach useful for studying dysbiosis-related skin conditions such as acne, atopic dermatitis, and psoriasis. Another benefit of this process is that it gives the ability to study how the microbiome influences the bioavailability, pharmacokinetics and pharmacodynamics of topical drugs and formulations.

Labskin works closely with local universities to conduct clinical panels to test client’s products on selected microbiomes, choosing by age, ethnicity, and skin condition. From this work the Labskin data bank of gene, physical and health markers on microbiome and skin cells was developed.

This database allows AI modelling of skin conditions and ingredient effects – a game-changer for the human and clinical trials aspects of skincare and cosmetics.

Covid-19 has stalled progression for many of Labskin’s clients during the worldwide lockdown. While developing the database it became clear that many different samples of human skin are needed to perfect the Labskin skin model for each clients’ requirements.

Remote Clinical Trials – The Science Behind the Simplicity

In the pre-covid world, Labskin’s clients ordered tests for specific ingredients/formulations and indicated the type of skin they wanted tested – age, ethnicity, gender, part of the body etc. While growing the blank skin the cohort is identified by the client. A specific list of volunteers is then created and then under ethical guidelines the volunteers attend the Labskin laboratories.

The trialists are made aware of protocols, complete the required questionnaires and then a technician takes a swab. The swab is tagged and frozen until its skin is ready. Then the sample is unfrozen and the microbiome transferred to lab grown skin for the tests to start.

Depending on the depth of the trial, the human test and the virtual tests of that cloned human skin microbiome can happen in parallel or testing can just be performed on the clone. Certain cosmetic clinical trials just measure subjective or superficial effects of the products whereas the Labskin model allows deeper understanding of how the products work at the molecular level. The end result is a report by Labskin skin specialists backed up by data that outlines changes to the microbiome and the skin physiology.

Results are placed in the customers virtual vault where they are interrogated and suggestions for changes to ingredients and new tests can be specified. For damaged skin Labskin AI is used to absorb this data and suggestions made to change/amend formulas. As the Labskin skin microbiome data bank is extended, so does the knowledge of the AI extend to numerous skin types.

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 question. However with social distancing, it became obvious that the Labskin process would have to adapt. Human trialists could not be put at risk of infection through either travelling to laboratories or close contact swab-taking.

While in lockdown the Labskin software team adapted and added new modules on the Labskin platform to create a totally online system that allows human volunteers to self-swab under video supervision and post their results to the labs where the skin clone can be grown for testing. All of the clinical testing protocols, questionnaires and documentation are now hosted online.

The Labskin store, share and collaborate data platform has also been upgraded to ensure all data collected is encrypted and stored securely to meet GDPR guidelines. This is important as it highlights that 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

  1. The trialist is posted a pack. This pack has an RFID which brings up a web application on any type of computer – mobile, tablet or desktop – to log directly in.
  2. Documentation and questionnaires required are answered, filled in and signed online.
  3. A video screen automatically launches with instructions to the trialist on how to take the swab.
  4. The swab taking is recorded and added to the trialists file. AI will indicate to the trialist if the proper procedure taking the swab has been followed.
  5. The swab is put in a proprietary container and placed in the household freezer for 24 hours.
  6. After 24 hours, where reminders are also sent via text, the container is placed back in the container and mailed to Labskin.

Labskin has demonstrated that the microbiome, when isolated in this manner, remains viable in transit for at least 48 hours thanks to the proprietary container which maintains the integrity of the swab.Once the container is received in the lab within those 48 hours the microbial mix is viable.

The RFID code identifies the subject and relevant trial and the subject’s microbiome can then be used directly on Labskin or stored for later cloning onto blank skin models for additional testing.

The remote clinical trial with the human subject regularly swabbing and posting results of their microbiome for sequencing and the cloned trials and sequencing results happen in parallel and merge to a comprehensive report on the effectiveness of the product being tested.

In the Covid 19 world, this new platform has many benefits:

  1. Clients get to continue clinical trials with data and analysis precisely compared to human tissue models in laboratories that allows faster route to market for new and adapted existing products.
  2. Clients get clinical trial data precisely compared to data on human tissue models
  3. Labskin continues adding value to its clients and keeps helping to extend the breadth and scope of knowledge around the skin microbiome
  4. Labskin builds a skin microbiome bank that is used to further train our AI models.