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Petah Tikva, Israel

Power Paper Ltd

Petah Tikva, Israel
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Amichai B.,Clalit Health Services | Mosckovitz R.,Power Paper Ltd | Trau H.,Sheba Medical Center | Sholto O.,Power Paper Ltd | And 5 more authors.
Mycopathologia | Year: 2010

Background: Onychomycosis is a common disease. Topical treatment is usually not effective due to limitation of trans-nail delivery of antifungal drugs. Successful treatment of deep-seated nail infections remains elusive as the delivery of efficacious levels of antifungal drug to the site of action is very difficult. Objectives: To evaluate the influence of several parameters including; the effect of low electrical current, incubation time and the presence of electrolyte (NaCl or KCl) on the penetration of terbinafine through the nail plate into the nail bed, using various formulations and concentrations of terbinafine HCl. Methods: Iontophoresis was applied across porcine and human nail in vitro to assess its efficiency in enhancing delivery of terbinafine HCl. Results: In this study, we have demonstrated that an optimal electrolyte concentration (1% NaCl or KCl) is required for an effective delivery. There is a significant increase in drug delivery into the nail and into the receiving compartment in the presence of 3% DMSO. Conclusions: This study demonstrates the efficacy of iontophoresis in enhancing the trans-nail delivery of terbinafine. Clinical studies are needed to evaluate the feasibility, efficacy and safety of iontophoresis of terbinafine in onychomycosis in human. © 2009 Springer Science+Business Media B.V.


Amichai B.,Sheba Medical Center | Nitzan B.,Power Paper Ltd | Mosckovitz R.,Power Paper Ltd | Shemer A.,Sheba Medical Center
British Journal of Dermatology | Year: 2010

Background Onychomycosis is a common disease; topical treatment is usually poorly effective, while systemic treatment is more effective but may be associated with side-effects. Iontophoretic drug delivery may improve drug penetration through the nail and lead to better therapeutic results. Objectives To evaluate the efficacy, safety and tolerability of topical treatments with terbinafine HCl delivered with or without an iontophoretic patch in patients with onychomycosis of the toenails. Methods Patients enrolled into the study were divided randomly into two groups. Group A was treated with terbinafine and an iontophoretic patch (at a constant current density of 100 μA cm -2). Group B was treated with terbinafine without iontophoresis. Treatment was overnight wear, every day, 5 days per week, for 4 weeks. Follow-up period was 8 weeks from the end of treatment. Results A significant clinical response was recorded in patients of group A (active group). The percentage of patients having healthy toenail growth of more than 1·5 mm at the end of treatment was 40% compared with 11% in patients treated with terbinafine without current (passive group). The percentage of patients having fungal elements (KOH) in nail specimens decreased significantly at 8 weeks following the completion of treatment: 16% in the active group vs. 53% in the passive group. Patients in the active group reported a tingling sensation that is expected when using an iontophoretic drug delivery treatment. Conclusions The delivery of terbinafine under an electrical current of 100 μA cm-2 appears to be efficacious and safe and is well tolerated for the treatment of nail onychomycosis. © 2009 British Association of Dermatologists.

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