February 19, 2019
First patient has been successfully treated in Medical Ethics Pty Ltd Phase IIa study of Tri-Solfen® (for human use the product will be branded as Medi-Solfen®) for the treatment of pain prior and post-surgical debridement of venous leg ulcers.
This first-in-man study is being conducted at the Welsh Wound Innovation Centre in Wales, United Kingdom, with headline data expected in H2 2019.
Professor Keith Harding, Principal Investigator, Welsh Wound Innovation Centre, commented: “We are pleased to initiate this important study looking at mitigating pain for patients with venous leg ulcers. The first patient was successfully treated, allowing the wound to be fully debrided without any reported sensation or pain. Pain associated with venous leg ulcers is a significant unmet need, and I am excited by the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in such wounds. I look forward to delivering the full data following completion of the clinical trial.”
Allan Giffard, Managing Director of Medical Ethics, added: “I am pleased to announce the successful treatment of the first patient with Medi-Solfen® in our Phase IIa clinical trial for the treatment of pain prior and post-surgical debridement of venous leg ulcers. This first-in-man trial is an important milestone for Medical Ethics, with Medi-Solfen® being our first product candidate for human use progressed for clinical development, as we move towards building a proprietary wound care and pain mitigation platform. We look forward to announcing headline data from the clinical trial in H2 2019.”
Medi-Solfen®, Medical Ethics’ lead product candidate for human use, is an innovative medicine designed to provide rapid onset and both short and prolonged analgesia effects for up to 24 hours. The topical gel contains two local anesthetic agents and an antiseptic, and other active ingredients, designed to minimize bleeding and potentially protect against infection as well as promote healing.
The Phase IIa clinical trial will assess the safety and efficacy profile of Medi-Solfen® in providing anesthesia when applied topically to venous leg ulcers, prior to and post-surgical debridement. The open, randomized, parallel group-controlled study is being conducted in 90 patients in three successive stages, which aims to study the time taken to achieve surface anesthesia, degree of post-operative pain relief and patient’s assessment of overall quality as an anesthetic during this procedure. Secondary objectives of the study include the duration and quality of post-operative pain relief following a single-dose, levels of anesthesia achieved, and influence on the early healing trajectory of the leg ulcer.
Patients with venous leg ulcers report pain to be the worst aspect of having an ulcer, especially during debridement.1-4 Pain tolerated over a long time can cause a negative mood, decreased activities of daily living, sleep disturbance, reduced mobility and social withdrawal.5 In the UK alone, there are 278,000 venous leg ulcers being treated per annum, plus an additional 420,000 leg ulcers with no specific classification, however, it is broadly accepted that a number of these are venous in origin.6
- Lindholm, C., Bjellerup, M., Christensen, O. B. and Zederfeldt B. (1993) Quality of life in chronic leg ulcer patients. An assessment according to the Nottingham Health Profile. Acta Derm Venereol. Volume 73, issue 6, pp. 440-443.
- Walshe, C. (1995) Living with a venous ulcer: a descriptive study of patients experiences. Journal of Advanced Nursing. Volume 22, issue 6, pp. 1092–100.
- Phillips, T., Stanton, B., Provan, A. and Lew, R. (1994) A study of the impact of leg ulcers on quality of life: Financial, social and psychologic implications. Journal of American Academy of Dermatology. Volume 31, issue 1, pp. 49–53.
- Moffatt, C. (2002) Pain at wound dressing changes. EWMA positioning document.
- Franks, P.J. and Moffatt, C. (2001) Health related quality of life in patients with venous ulceration: use of the Nottingham health profile. Quality of Life Research. Volume 10, issue 8, pp. 693-700.
- Guest J., Fuller, G.W., and Vowden P. (2018) Venous leg ulcer management in clinical practice in the UK: costs and outcomes. International Wound Journa;18:29-37l