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Evaluation of efficacy and tolerability of four weeks bifonazole treatment after nail ablation with 40% urea in mild to moderate distal subungual onychomycosis.

BACKGROUND
The aim of this study was to verify efficacy and tolerability of sequential therapy with 40% urea paste followed by 1% bifonazole urea in mild to moderate distal subungual onychomycosis of the toenails.


METHODS
It was an seven weeks open study. Sequential patients affected by mild to moderate distal subungual onychomycosis of the toenails agreed to apply on the affected nail 40% urea paste in occlusion overnight for the first three weeks, with gentle scraping with a spatula the following day, followed by 1% bifonazole cream once a day for 4 weeks. Efficacy evaluation was based on mycology, clinical photography and investigator and patient assessment. Tolerability assessment included subjective and objective evaluations.


RESULTS
The ten patients enrolled (mean age 57.5 years) completed the study. Onychomycosis was caused in nine cases by dermatophytes and by Scopulariopsis brevicaulis in one patient. At the end of the study, mycological examination was negative in all 10 patients. Clinical photographs showed a reduction of the percentage of the nail affected by onychomycosis in 8 cases, cure in 2 and considerable reduction of the nail thickness, already evident after 7 days. All patients reported to be satisfied by the treatment, which was judged easy to perform and well tolerated.


CONCLUSIONS
Treatment with urea and bifonazole is effective and well tolerated, and easy to do also by elderly patients.