SkinBioTherapeutics pleased with first human study results

Skin health-focussed life sciences company SkinBioTherapeutics released the results of its first human study on Monday, which was primarily undertaken to show the effects of its ‘SkinBiotix’ product on the barrier of healthy skin.

The AIM-traded firm said an important secondary endpoint was to show that the technology was safe and well-tolerated in a large group of people using it twice a day for an extended period of time - in this case, 129 people over 29 days.

It said the results of the independent study demonstrated that SkinBiotix was safe, well tolerated and had efficacy in certain age groups and time points.

The study design involved three groups, with the first group applying the active cream containing SkinBiotix to one leg and nothing to the other.

SkinBioTherapeutics said the second group applied cream containing no SkinBiotix - the ‘vehicle’ - to one leg and nothing to the other, while the third group applied the active cream to one leg and the cream containing no SkinBiotix to the other.

Measures of the barrier were then performed in all groups at 15 days and 29 days.

The company said primary measures were corneometry, which is a measure of how hydrated the skin is; and transepidermal water loss (TEWL), which is a measure of water loss from the skin.

A change to the barrier could be expected to be reflected in an increase in skin hydration or a reduction in TEWL.

Some additional measurements of skin elasticity were also taken, the firm explained.

The data showed that none of the 129 volunteers experienced any adverse skin reactions to the active cream.

It also showed a “statistically significant” increase in skin hydration at day 15 with the active, which was better than that produced by the vehicle.

That effect was seen in the group under 50 years old, and at day 29 there was “no difference” in skin hydration between any of the groups.

A small but statistically significant decrease was seen in TEWL with the active at day 29 in the group over 60 years old.

In other age groups and also in measures of skin elasticity, SkinBioTherapeutics said there was no difference between the vehicle and the active.

The results of the independent study demonstrated that SkinBiotix was safe, well tolerated and had efficacy in certain age groups and time points, the board reiterated.

That change in skin hydration and water loss were in line with the company’s expectations from laboratory studies, which showed that SkinBiotix increased the levels of proteins within the skin that were crucial for a healthy barrier.

The increase in skin hydration in the younger group at day 15 could reflect the ability of younger skin to respond to SkinBiotix faster than older skin, the board said.

“We are really pleased by these data,” said SkinBioTherapeutics chief executive officer Dr Cath O'Neill.

“To show efficacy at this stage of development is very exciting since there is a lot of scope for us to further optimise the formulation, potentially altering the dose of the SkinBiotix to make it more suitable for different age groups.

“It is very difficult to change a healthy barrier and therefore the data showing improvement in some age groups gives us confidence in our partner discussions, and in seeking to develop future applications in disease conditions where the barrier is known to be poor such as eczema.”