Topical treatment of onychomycosis with amorolfine 5% nail lacquer: comparative efficacy and tolerability of once and twice weekly use.
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.
Reinel
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Department of Dermatology, Bundeswehrkrankenhaus, Hamburg, FRG.
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy; D006801:Humans; D007764:Lacquer; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy*; D011897:Random Allocation
D000935:Antifungal Agents; D009025:Morpholines; C038974:amorolfine