Amorolfine and itraconazole combination for severe toenail onychomycosis; results of an open randomized trial in Spain.
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.


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 1-12). 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 1-12. 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.
Lecha
M
M
Hospital Clinic Barcelona, Spain. 4908mlc@comb.es
D000284:Administration, Oral; D000287:Administration, Topical; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D005533:Foot Dermatoses / Q000188:drug therapy; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy*; D016896:Treatment Outcome; D014249:Trichophyton
D000935:Antifungal Agents; D009025:Morpholines; D017964:Itraconazole; C038974:amorolfine