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.