Clinical evaluation of fenticonazole cream in cutaneous fungal infections: a comparison with miconazole cream

Abstract

A randomized, double-blind, parallel-group, multi-centre clinical trial was undertaken in 60 patients with dermatophytosis or pityriasis versicolor to compare topical 2% fenticonazole cream with topical 2% miconazole cream. Treatment, by twice-daily application, was for 4 weeks or until earlier complete resolution of disease. Assessment was by laboratory mycological investigation and regular clinical/symptomatic evaluation, both during and for 2 to 6 weeks after therapy. Fifty-three patients satisfactorily completed the trial, 28 of whom received fenticonazole and 25 miconazole. The groups were adequately well-matched. All assessment criteria showed fenticonazole to be at least as efficacious as miconazole, with no statistically significant differences between the two treatments. A number of assessment criteria, however, did show trends in favour of fenticonazole. Fenticonazole resulted in mycological findings becoming negative in 92%, i.e. all but 2 of 25 patients, by the end of treatment and a similar proportion (91%, 21 of 23 patients) remained mycologically negative 2 to 4 weeks after the end of therapy. With miconazole, only 79% (19 of 24 patients) became mycologically negative during treatment and this figure decreased further to 74% (14 of 19 patients) after therapy. Essentially similar results were seen for clinical assessments of erythema, itching and desquamation, these features being significantly and progressively eliminated or improved by both treatments in high proportions of patients during therapy, followed by little tendency to return after the cessation of therapy. Overall clinical assessments demonstrated statistically significant improvement during the second, third and fourth weeks of treatment with both drugs. Only 4 patients (two with each treatment) were reported as showing clinical deterioration at any stage during the trial, in all cases after the end of therapy. There were no reports of local or systemic adverse reactions to either drug, and laboratory screening investigations failed to reveal any signs of toxicity. These results indicate that a 4-week course of twice daily topical 2% fenticonazole cream is extremely well tolerated and is at least as efficacious as an equivalent regimen of 2% miconazole for the treatment of cutaneous dermatophytosis or pityriasis versicolor. Trends in the results suggest that fenticonazole may prove to be more efficacious than miconazole, particularly in relation to elimination of laboratory evidence of persistent fungal infection, which could be reflected in a lower incidence of subsequent relapse of the disease.