December 17, 2018
The MHRA has approved Phase IIa clinical trial application for Tri-Solfen (for human use) for venous leg ulcers. The product will be branded as Medi-Solfen.
Medi-Solfen, Medical Ethics’ lead product candidate for human use, is an innovative medicine designed to provide rapid onset and both short and prolonged analgesic 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 will be conducted in 90 patients in three successive stages, which aim to study the time taken to achieve surface anesthesia, degree of postoperative pain relief, and patient’s assessment of overall quality as an anesthetic during this procedure.
Secondary objectives include the duration and quality of postoperative pain relief following a single-dose, levels of anesthesia achieved, and influence on the early healing trajectory of the leg ulcer. We anticipate initiating the clinical trial in Q1 2019.
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
Allan Giffard, Managing Director of Medical Ethics, commented: “We are thrilled to announce the MHRA approval of our Phase IIa clinical trial design for Medi-Solfen® for the treatment of pain during the surgical debridement of venous leg ulcers. The application is based on an extensive body of evidence, which demonstrates the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in wounds and we look forward to investigating this further in venous leg ulcers, where there is a significant unmet patient need.
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 proprietary wound care and pain mitigation platform.”
- 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