Butenafine hydrochloride (Mentax (R)) cream for the treatment of hyperkeratotic type tinea pedis and its transfer into the horny layer, with or without concomitant application of 20% urea ointment (Keratinamin (R))

Forty-five patients were divided into two groups: group I, 23 patients, tre ated with butenafine hydrochloride (Mentax(R)) cream alone, and group II, 2 2 patients, treated with butenafine hydrochloride and 20% urea ointment (Ke ratinamin(R)) to evaluate the usefulness of the treatments. We also measure d the transfer of these drugs to the horny layer in some patients. The clin ical improvement rate of dermatological symptoms (marked improvement + impr ovement) was 91.3% in group I, 100% in group II, with therapeutic effects e vident earlier in group II than in group I. The mycological eradication rat e was found to be 47.4% in group I, 50.0% in group II after 4 weeks of trea tment, and 81.8 and 87.5% at 12 weeks thereafter, respectively, with no adv erse reactions found. The clinical utility rate (markedly useful+useful) wa s 91.3% in group I and 86.4% in group IL These results demonstrate that app lication of butenafine hydrochloride alone was extremely effective for the treatment of hyperkeratotic-type tinea pedis and that combination applicati on with urea. ointment resulted in an earlier improvement of dermatological symptoms. The concentration of butenafine in the horny layer from healthy volunteers reached a steady state in both groups I and II at 2 weeks after the application, with a lower concentration found in group II (about 70 ng mg(-1)) than in group I (about 100 ng mg(-1)). Although some variations in concentration were found in case by case, patients in whom the treatment wa s determined to be 'markedly effective and effective' showed the increase i n concentration of the drug in the lesional horny layer to be directly prop ortional to the number of days of treatment, with a lower concentration fou nd in group II than in group I. This trend was also seen in healthy volunte ers.