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Amorolfine and itraconazole combination for severe toenail onychomycosis; results of an open randomized trial in Spain
Author(s) -
Lecha M.
Publication year - 2001
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2001.00044.x
Subject(s) - itraconazole , medicine , randomized controlled trial , surgery , clinical trial , combination therapy , dermatology , antifungal
Objective In an open, randomized, clinical study of toenail onychomycosis with matrix area involvement, two alternative regimens of topical amorolfine/oral itraconazole therapy were compared with itraconazole monotherapy. Patients/Methods A total of 131 patients were randomized to treatment. Patients in the combination groups were treated with amorolfine 5% nail lacquer (Loceryl®, Galderma Laboratories) once weekly for 24 weeks and 200 mg itraconazole once daily for 6 weeks (Group AI‐6) or 12 weeks (Group AI‐12). A control group received itraconazole monotherapy for 12 weeks (Group I‐12). Strict inclusion criteria specified that subjects had to have onychomycosis of the toenails with matrix area involvement and/or > 80% total nail surface involvement. Mycological evaluations using both microscopic examination and culture of nail samples were performed at weeks 12 and 24. A stringent assessment of outcome at study end combined the results of mycological and clinical outcomes into a global cure rate. Safety was also assessed. Results At week 12, mycological cure was attained in 42 of 45 patients (93·3%) in group AI‐6, 29 of 35 patients (82·9%) in group AI‐12, and 14 of 34 patients in group I‐12. The difference between both combination groups and the control group were significant ( P < 0·001). The global cure rate at week 24 was 83·7% (36 patients) in group AI‐6, 93·9% (31 patients) in group AI‐12, and 68·8% (22 patients) in group I‐12. The difference between the AI‐12 group and itraconazole monotherapy was significant ( P < 0·05). Conclusions These results indicate that amorolfine combination therapy represents an improved treatment strategy for patients with severe onychomycosis.