Source: DGNews  |  Posted 4 years ago

By Bruce Sylvester

SAN ANTONO, TX -- February 11, 2008 -- Treatment of moderate to severe toenail dermatophyte onychomycosis with pulse terbinafine and ciclopirox nail lacquer is more effective than terbinafine monotherapy, researchers reported here at the American Academy of Dermatology 66th Annual Meeting (AAD).

"The treatment of toenail onychomycosis with terbinafine is an established practice. By reducing the total dose of terbinafine and combining it with a topical therapy, it was hypothesised that similar or greater efficacy of treatment may be obtained compared to terbinafine monotherapy, without increasing the risks of adverse events," the study authors stated in their poster, presented on February 3.

For their randomised, parallel-group, evaluator blinded trial, the investigators enrolled 864 subjects (550 evaluable at week 84) with toenail dermatophyte onychomycosis. They treated 414 subjects with daily ciclopirox nail lacquer for 48 weeks and three 2-week pulses of terbinafine 250 mg from weeks 12 to 24. Some of the subjects received terbinafine booster therapy at week 36 and/or week 60, as required. In addition, the researchers treated 450 subjects with daily placebo nail lacquer for 48 weeks and three 2-week pulses of terbinafine from weeks 12 to 24.

The group given the active treatment combination achieved an overall effective cure rate of 48.4% at week 84. They defined "effective cure" as mycological cure (negative potassium hydroxide and culture) with less than 10% visually affected area of nail remaining. Subjects treated with placebo nail lacquer and terbinafine achieved an overall effective cure rate of 32.8%. The difference did not reach statistical significance.

According to the authors, this study is the first large-scale investigation to evaluate the combination of ciclopirox lacquer with a reduced terbinafine pulse regimen administered for 2 weeks on and 2 weeks off for 12 weeks. T

"The effective cure rates were higher particularly in the reduced terbinafine/ciclopirox groups with low-moderate and severe gradings, though not the high-moderate grade," the researchers concluded. "Further investigation into the efficacy is required."

"Based on these results, a reduced terbinafine/ciclopirox regimen provides a safe alternative to standard terbinafine," they added.

Funding for this study was provided by sanofi-aventis.

[Presentation title: Phase IV Study of the Efficacy and Safety of a Pulse Terbinafine/Ciclopirox Lacquer Regimen With a Continuous Terbinafine Regimen. Poster 1407]