Topical Treatment of Onychomycosis with Amorolfine 5% Nail Lacquer: Comparative Efficacy and Tolerability of Once and Twice Weekly Use

Abstract

456 patients with onychomycosis were treated once or twice weekly for up to 6 months with amorolfine 5% nail lacquer in an open, randomized study. The patients were examined at monthly intervals during treatment and followed-up 1 and 3 months after completion of treatment. Slightly better cure rates were achieved with twice weekly use than with once weekly use (overall cure rates 54.2 vs. 46.0% p = 0.4). An overall cure or improvement was achieved in 74 and 68% of patients receiving twice- and once-weekly treatment, respectively. The mycological cure rate was 76.1% for twice-weekly treatment and 70.6% for once-weekly treatment. The nail lacquer was extremely well tolerated; 4 out of 456 patients reported mild local irritation. Plasma levels of amorolfine were determined in 19 patients and found to be below the detection limit of 0.5 ng/ml in all cases.

A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis

“…Most studies with nail lacquers are >15 years old or did not assess complete cure at 1 year which is the gold standard for onychomycosis treatment evaluation [20] . There is some new evidence regarding the efficacy of nail lacquers when used alone for the treatment of onychomycosis [7] .…”

Activity of TDT 067 (Terbinafine in Transfersome) against Agents of Onychomycosis, as Determined by Minimum Inhibitory and Fungicidal Concentrations

“…For example, the 28% formulation of tioconazole was reported to have a cure rate of only 20 to 22% (19). A multicenter study of 456 patients demonstrated a 54% clinical response rate for amorolfine nail lacquer; however, patients in this study had no nail bed involvement (27). Ciclopirox, the only FDA-approved topical agent for the treatment of onychomycosis in the United States, achieves drug concentrations in the nail considerably higher than the MIC of ciclopirox for dermatophytes (5).…”

Is This the Right Drug or the Dose for the Management of Onychomycosis?

“…In those cases, combination therapy has been found to be promising in ameliorating the overall cure rate of onychomycosis [52][53][54][55]. The use of combination approach and the application of antifungal drug synergy is a wellknown concept in mycology.…”

“…The use of combination approach and the application of antifungal drug synergy is a wellknown concept in mycology. The combination of two or more drugs can result in augmented efficacy, rapidity of effects, a broader spectrum of activity and improved patient tolerability [55][56][57][58][59]. The benefits of combination therapy were first shown with griseofulvin as the standard therapy for the treatment of onychomycosis (due to dermatophytes) for the last 30 years.…”