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  • Title: Butenafine hydrochloride (Mentax) 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).
    Author: Tanuma H, Doi M, Ohta Y, Abe M, Kume H, Mukai H, Katsuoka K.
    Journal: Mycoses; 2001; 44(7-8):287-99. PubMed ID: 11714064.
    Abstract:
    Forty-five patients were divided into two groups: group I, 23 patients, treated with butenafine hydrochloride (Mentax) cream alone, and group II, 22 patients, treated with butenafine hydrochloride and 20% urea ointment (Keratinamin) to evaluate the usefulness of the treatments. We also measured the transfer of these drugs to the horny layer in some patients. The clinical improvement rate of dermatological symptoms (marked improvement + improvement) was 91.3% in group I, 100% in group II, with therapeutic effects evident earlier in group II than in group I. The mycological eradication rate was found to be 47.4% in group I, 50.0% in group II after 4 weeks of treatment, and 81.8 and 87.5% at 12 weeks thereaftcr. respectively, with no adverse reactions found. The clinical utility rate (markedly useful + useful) was 91.3% in group I and 86.4% in group II. These results demonstrate that application of butenafine hydrochloride alone was extremely effective for the treatment of hyperkeratotic-type tinea pedis and that combination application 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 was determined to be 'markedly effective and effective' showed the increase in concentration of the drug in the lesional horny layer to be directly proportional to the number of days of treatment, with a lower concentration found in group II than in group I. This trend was also seen in healthy volunteers.
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