SkinBioTherapeutics plc (AIM: SBTX), a life science company focused on skin health, Provided the results of its first human study on 4/8/19.
The study was primarily undertaken to show the effects of SkinBiotix on the barrier of healthy skin. An important secondary endpoint was to show that the technology is safe and well tolerated in a large group of people (129) using it twice a day for an extended period of time (29 days).
The results of this independent study demonstrate that SkinBiotix® is safe, well tolerated and has efficacy in certain age groups and time points.
The study design involved three groups:
- Group 1 applied the active (cream containing SkinBiotix) to one leg and nothing to the other
- Group 2 applied the vehicle (cream containing no SkinBiotix) to one leg and nothing to the other
- Group 3 applied the vehicle to one leg and active to the other.
Measures of the barrier were then performed in all groups at 15 days and 29 days. The primary measures were Corneometry – a measure of how hydrated the skin is, and Transepidermal water loss (“TEWL”) -a measure of water loss from the skin. A change to the barrier might 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 data showed:
None of the 129 volunteers experienced any adverse skin reactions to the active.
2) A statistically significant increase in skin hydration at day 15 with the active, which was better than that produced by the vehicle. This effect was seen in the group under 50 years old. At day 29 there was no difference in skin hydration between any of the groups.
3) A small but statistically significant decrease in TEWL with the active at day 29 in the group over 60 years old.
4) In other age groups and also in measures of skin elasticity there was no difference between the vehicle and the active.
The results of this independent study demonstrate that SkinBiotix is safe, well tolerated and has efficacy in certain age groups and time points. The change in skin hydration and water loss are in line with our expectations from laboratory studies which have shown that SkinBiotix increases the levels of proteins within the skin that are crucial for a healthy barrier. The increase in skin hydration in the younger group at day 15 may reflect the ability of younger skin to respond to the SkinBiotix faster than older skin.
Dr Cath O’Neill, CEO of SkinBioTherapeutics, said:
“We are really pleased by these data. 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”.