Initial human tests of SkinBioTherapeutics PLC's (LON:SBTX) SkinBiotix cream have confirmed the product’s safety as well as delivering positive data regarding irritancy and moisturisation potential.
These initial results are effectively a precursor to the main element of the study involving 120 volunteers with dry skin. This kicks off later in November and will assess the longer-term moisturisation potential of the technology.
The company found in a smaller trial with 30 people that there was no reaction, or irritation even at 20-times the standard dose. Concentrations were incrementally increased and the volunteers were monitored at one-, two- and three-day intervals.
Repetitive tests
In the repetitive, longer-term tests of a group of 31, in which the cream was applied for 12 hours using exaggerated exposure methods, one person experienced irritation, which the company said occasionally happens.
“The irritation study results validate the safety element of our technology and provide further reasons for potential partners to speak to us,” said chief executive, Dr Cath O’Neill.
The second part of the three-stage test was to look at the moisturisation of SkinBiotix over 12 hours using a control group for comparison.
As in-house laboratory tests suggested the technology requires at least 24 hours to produce its effects, no difference between the groups was anticipated.
Good moisturisation
This proved to be the case. The cream containing SkinBiotix provided good moisturisation, which was generally higher than that provided by the control cream, but the difference was not significant, SkinBiotherapeutics said.
CEO O’Neill said the group had passed a “major milestone” by demonstrating the technology was safe, which allows for the commercialisation of the product.
She added: "We have always stated that we are a science-led company, therefore the larger moisturisation clinical trial that is due to commence later this month will be of key importance to us.
“We expect this data will demonstrate the long-term effects of our technology (greater than 24 hours) and the results will play a key part in the talks with commercial partners."