A Phase I study to assess the safety of three formulations of the dermal implant ELAPR

Elastin is a major structural component of the skin which enables the skin to stretch and recoil. The loss or damage of elastin in the skin results in a range of skin abnormalities including, the symptoms of skin aging such as wrinkles, scars and the signs of sun damage. ELAPR is a dermal implant which is made from a synthetic form of human elastin and is being developed as a product which may be injected superficially into the skin using very fine needles to treat skin abnormalities associated with the loss of elastin. The synthetic human elastin which is the basis of the ELAPR dermal implant is a completely new product and the purpose of the current clinical trial is to evaluate the safety of the product in humans. The trial will involve the implantation of a small volume of the product in the skin of the upper arm of study participants. The implant will remain in the skin for a period of up to 29 days. The implant will then be removed by a needle biopsy to allow studies to be carried out on the tissue surrounding the implant to see how the body responded to the presence of the implant in the skin. The results of this study will provide a good understanding of how well the body tolerates this new synthetic human elastin material. If the synthetic elastin is well tolerated by the body then further studies will be undertaken to study its use in the treatment of skin abnormalities resulting from aging, scarring and sun damage.