Medical Ethics managing director Allan Giffard said the UK’s Medicines and Healthcare products Regulatory Agency had recently approved a clinical trial of Tri-Solfen® for the treatment of pain during the surgical debridement of venous leg ulcers.
Mr Giffard said Tri-Solfen® was designed to provide both immediate and long term pain relief. The topical gel contained two local anaesthetic agents and an antiseptic, and other active ingredients, designed to minimise bleeding and potentially protect against infection as well as promote healing.
Tri-Solfen® was originally developed to provide pain relief to lambs and calves undergoing surgical animal husbandry practices.
Tri-Solfen® would be branded as Medi-Solfen® for human use, Mr Giffard said.
“The clinical trial will assess the safety and efficacy profile of Medi-Solfen® in providing anaesthesia when applied topically to venous leg ulcers, prior to and post-surgical debridement,” Mr Giffard said.
“The study will involve 90 patients in three successive stages, which aim to study the time taken to achieve surface anaesthesia, degree of post-operative pain relief and patient’s assessment of overall quality as an anaesthetic during this procedure.
“Secondary objectives include the duration and quality of post-operative pain relief following a single-dose, levels of anaesthesia achieved, and influence on the early healing trajectory of the leg ulcer.”
Mr Giffard said patients reported pain to be the worst aspect of having a venous leg ulcer, especially during the removal of dead or damaged skin, a process known as debridement. It is estimated that up to 700,000 venous ulcers are being treated in the UK each year.
“The application is based on an extensive body of evidence, which demonstrate the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in wounds,” Mr Giffard said.
“This approval is an important milestone for Medical Ethics, with Medi-Solfen® being our first product candidate for human use progressed for clinical development and as we move towards building a proprietary wound care and pain mitigation platform.”
Medi-Solfen® is a local anaesthetic and antiseptic gel. It contains two topical local anaesthetics; fast-acting Lidocaine for immediate pain relief and long-acting Bupivacaine for prolonged post-operative pain relief. Adrenaline is included to reduce the shock and stress of blood loss, while prolonging the anaesthetic action. Medi-Solfen® also contains Cetrimide; an antiseptic used to cleanse skin and wounds and provides protection from bacterial contamination.