New single-dose treatment of athlete's foot

Athlete's foot is estimated to affect about 15% of South Africa's adult population1 and is an area of dermatology and podiatry, with considerable non-compliance issues2, often due to the cumbersome nature of treatments. For the majority of sufferers, treatment has meant the frustration of messy, time-consuming, repeated applications of fungistatics.

By inhibiting the production of ergosterol, conventional fungistatics such as miconazole and clotrimazole have been effective. However, compliance has long been the real issue because of the treatment duration. It is widely documented that 48% of patients neglect the proper daily dosing schedule and 25% of patients stop treatment as soon as their symptoms have disappeared2. If one had to investigate a little deeper into patient complaints, most would admit that they find creams messy and they do not like touching the area for fear of cross-infection. Another complaint is that powders spread everywhere and are walked into carpets.

To resolve these issues, Lamisil® Film Forming Solution Once™ has been formulated to provide 1% terbinafine in a ‘single once-off application' - the cutaneous solution directly addresses both the issue of patient compliance and concentration of action. Novartis claims that immediately after application, the product will remain in a solution state for around a minute. As the solution dries, thereafter, it forms a film over the skin. This skin stays in place for around 72 hours, enabling the terbinafine to continue to permeate from the film matrix. It was also demonstrated that occlusion, as naturally occurs within the enclosed spaces of toes and the wearing of shoes and socks, increases the life of the film up to 96 hours.

Terbinafine is claimed to achieve fungicidal concentrations in the stratum corneum within 30 minutes and remain at these levels for up to 13 days3.

The efficacy of this new formulation 4 is claimed to be similar to the well established Lamisil 1% cream5, and in terms of safety and tolerability it was rated by 88% of patients and investigators as very good/good4.

Not only was a high cure rate from a single dose treatment demonstrated, but the treatment was also rated as easy to use by participants in the clinical studies, increasing its potential benefit in an area where non-compliance and consequently relapse are a significant issue.

Lamisil® Film Forming Solution Once™ is claimed to offer healthcare professionals the simple answer to address the issue of poor patient compliance and it could fundamentally revolutionise treatment, offering patients a “one hit” solution for a condition that has plagued many people for years.

References

[1] Evans E.G.V. The clinical efficacy of terbinafine in the treatment of fungal infections of the skin, Rev Contemp Pharmacother. 1997;8:325-41
2 Meinhof W, Girardi RM, Stracke A. Patient non compliance in dermatomycosis. Results of a survey among dermatologists and general practitioners. Dermatologica 1984;169 Suppl 1;57-66
3 Kienzler, J-L, Queille,-Roussel, C., Mugglestone, C., Ortonne, J-P, Larnier, C.. Stratum Corneum Pharmacokinetics of a Novel Terbinafine Formulation for Single Dose Treatment of Athlete's Foot. J Eur Acad Dermatol Venereol 2005 ; 19(S2) :FC02.7
4 Ortonne J.P., Korting H.C., Viguié-Vallanet C., Larnier C., Savaluny E. Efficacy and Safety of a Novel Single Dose Topical Terbinafine Formulation in Patients with Tinea pedis (Athlete's Foot): a randomized, double-blind placebo-controlled study. J Eur Acad Dermatol Venereol 2005 ; 19(S2) :P01.120
5 Korting H C, Tietz H J, Brautigam M, Mayser P Rapatz G et al One week terbinafine 1% cream (Lamisil) once daily is effective in the treatment of interdigital Tinea pedis: a vehicle control study Med Mycology 2001; 39:335-40