Amorolfine nail lacquer: clinical experience in onychomycosis

Abstract

Objective: The clinical usefulness of amorolfine in form of a nail lacquer in the treatment of onychomycoses is discussed. The results of the patients which applied amorolfine lacquer once weekly as monotherapy are reviewed. Also the preliminary results of a randomized study comparing amorolfine lacquer in combination with a short griseofulvin treatment versus the standard long term griseofulvin oral treatment in patients with severe nail affection are reported.Background: Amorolfine is a broad spectrum antifungal active in vitro against dermatophytes, yeasts and moulds. This substance has been incorporated in a lacquer, an innovative galenical form, to treat onychomycosis.Methods: In the framework of three large studies, 714 patients with onychomycosis without matrix involvement applied amorolfine nail lacquer once-weekly for six months. In an ongoing, open-comparative, randomized study, 194 patients with toe nail (and/or, in a few cases, finger nail) dermatophytosis were treated; lunulae/ matrices were affected in most of them. One group applied amorolfine nail lacquer twice-weekly for 12 months, and took griseofulvin (500 mg twice-daily) for the first two months. The other group received griseofulvin only (500 mg twice-daily for the first two months and once-daily for the remaining 10 months).Results: In the patients treated with amorolfine nail lacquer once-weekly for six months, clinical cure or improvement was observed in 77.6% of all toe nail mycoses, and in 83.7% of all finger nail mycoses, three months after the end of treatment. Mycological cure, including negative culture and microscopy, was achieved in 52.1% of the 424 toe nail, and in 64.3% of the 98 finger nail mycoses. Local adverse events probably or possibly related to the nail lacquer, mostly skin irritations, were reported in six patients (< 1%).In the comparative study, the clinical cure and improvement rates (including intact lunulae/matrices) in the group receiving the combined treatment and that treated with griseofulvin only, were 80.7% and 79%, respectively, three months after the end of treatment. Both culture and microscopy were negative in 62.9% of assessments in the first, and 50% in the second group. The most reported adverse events were headache, nausea and vomiting.Conclusions: Amorolfine lacquer once-weekly, has been shown to be effective and safe as monotherapy in onychomycosis without matrix involvement. Preliminary results in patients with severe onychomycosis needing oral therapy, suggest that by combining amorolfine nail lacquer with griseofulvin, the duration of the exposure to griseofulvin can be shortened to two months. Hence toxicity risks of oral therapy is reduced.