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Amorolfine in the treatment of onychomycoses and dermatomycoses (an overview)
Author(s) -
ZAUG M.,
BERGSTRAESSER M.
Publication year - 1992
Publication title -
clinical and experimental dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.587
H-Index - 78
eISSN - 1365-2230
pISSN - 0307-6938
DOI - 10.1111/j.1365-2230.1992.tb00281.x
Subject(s) - medicine , dermatology , trichophyton rubrum , adverse effect , nail (fastener) , regimen , candida albicans , dermatophyte , surgery , antifungal , microbiology and biotechnology , biology , materials science , metallurgy
A total of 727 patients with onychomycosis were treated for 6 months (range 1–14 months) with does of amorolfine lacquer ranging from 2 to 5% once or twice weekly. The 5% lacquer taken once weekly was more effective than the 2%. At the follow‐up visit 3 months after the end treatment, a mycological and clinical cure was achieved in 45–50% of the patients treated once or twice weekly. The mycological cure was 68% with T. rubrum , 88% with T. mentagrophytes and 81% with Candida albicans infections. Seven (0·96%) out of 727 patients had minor local adverse events. The recommended dosage regimen in patients with onychomycosis due to dermatophytes, yeasts or moulds is to apply the 5% amorolfine nail lacquer once or twice weekly until clinical cure, usually for 6 (finger nails)–12 months (toe nails). Within the framework of two double‐blind, multicentre studies and one open, clinical‐pharmacokinetic single‐centre study, a total of 914 patients with dermatomycosis localized on the feet, skin folds or other skin areas were treated with 0·125%, 0·25% or 0·5% amorolfine cream. The cream was applied once daily for 4 weeks on average. The most common pathogens isolated at screening were T. rubrum and T. mentagrophytes . One to three weeks after the end of treatment, the mycological and clinical cure rates, respectively, for patients in the 0·25% cream group (total 229 patients evaluable for efficacy) were as follows: 86·4 and 84·5% in fungal foot infections; 81·1% and 81·4% in mycosis of skin folds; and 79·1% and 89·6% in mycosis affecting other skin areas. The incidence of local adverse events such as burning, itching or erythema in 305 patients treated with 0·25% cream and evaluable for safety was 4·9%. The 0·25% cream was nearly as effective as the higher concentration and at the same time better tolerated (especially when applied on the skin folds). For therapeutic use in patients with dermatomycosis, 0·25% amorolfine cream applied once daily for 3–4 weeks is recommended.