Amorolfine is a structurally unique, topically active
antifungal agent, which possesses both fungistatic and fungicidal activity in vitro. Its spectrum of in vitro activity includes dermatophyte, dimorphic, some dematiaceous and filamentous fungi, and some yeasts. In clinical trials, application of
amorolfine 5% nail lacquer once or twice weekly for up to 6 months produced mycological and clinical cure in approximately 40 to 55% of patients with mild
onychomycosis 3 months after cessation of
therapy. Overall cure and improvement was observed in approximately 85 to 90% of patients with superficial
dermatomycoses following treatment with
amorolfine 0.25% cream for up to 6 weeks. However, few controlled, comparative trials are available for these different
mycoses, and only small numbers of patients have been evaluated to date. Both preparations appear to be well tolerated; only minor localised adverse events have been reported in clinical trials. At present, the major potential indication for topical
amorolfine appears to be
onychomycosis. Within this clinical setting,
amorolfine should be reserved for patients with mild
infection without nail matrix involvement. Systemic
therapy, however, remains essential for patients with severe intractable
onychomycosis involving the nail bed. Evidence to date does not clarify whether the use of adjuvant topical
amorolfine reduces the need for systemic
therapy in patients with severely infected nails, or whether
amorolfine is beneficial in individuals unresponsive to other treatment options.