In this study, in addition to studying the efficacy and safety of the once-daily administration of 100-mg capsules of fluconazole over an 8-week administration period with six patients with hyperkeratotic-type tinea pedis, we also measured the serum and horny layer concentrations of fluconazole to study the mobility into the horny layer in diseased areas of the sole skin. The final overall efficacy and overall safety were both 100% (six out of six), and no side-effects, including abnormal laboratory changes, were observed in any of the patients. The drug mobility study revealed that in the horny layer of the skin a steady state was reached after 4 weeks of administration, with the mean concentration being 12.8 micrograms g-1. This concentration was a high concentration that was no less than 13 times the geometric mean MIC (0.972 microgram ml-1) for fresh clinical isolates of Trichophyton rubrum. Based on the above results, fluconazole is considered to be highly useful for treating various kinds of dermatomycosis, including hyperkeratotic-type tinea pedis.
The usefulness of 1% terbinafine HCl (Lamisil) cream for hyperkeratotic-type tinea pedis and its transfer into the horny layer were evaluated. Of the 36 patients enrolled in the study, 35 were retained for analysis and one was excluded due to inappropriate drug application. Hyperkeratotic-type tinea pedis was classified into three types: true hyperkeratotic-type, partial hyperkeratotic-type, and quasi-hyperkeratotic type. The overall clinical improvement rate was 95.5% (100% for true-, 80% for partial- and 96.2% for quasi-hyperkeratotic type). The overall fungal eradication rate was 88.6% (75% for true-, 100% for partial- and 88.5% for quasi-hyperkeratotic type). The overall efficacy rate was 88.6% (75% for true-, 100% for partial- and 88.5% for quasi-hyperkeratotic type). No adverse reactions were reported. Drug concentrations in the horny layer were 170.3, 228.5 and 249.2 ng mg-1, respectively, 2, 4 and 12 weeks after starting the treatment. These concentrations are more than 50,000 times higher than the minimum inhibitory concentrations of terbinafine for dermatophytes. These findings indicate that terbinafine HCl (Lamisil) cream is very useful for refractory hyperkeratotic-type tinea pedis when administered alone. The pharmacokinetic data also support the clinical and mycological findings.
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.
The usefulness of 1% terbinafine HCl (Lamisil) cream for hyperkeratotic-type tinea pedis and its transfer into the horny layer were evaluated. Of the 36 patients enrolled in the study, 35 were retained for analysis and one was excluded due to inappropriate drug application. Hyperkeratotic-type tinea pedis was classified into three types: true hyperkeratotic-type, partial hyperkeratotic-type, and quasi-hyperkeratotic type. The overall clinical improvement rate was 95.5% (100% for true-, 80% for partial- and 96.2% for quasi-hyperkeratotic type). The overall fungal eradication rate was 88.6% (75% for true-, 100% for partial- and 88.5% for quasi-hyperkeratotic type). The overall efficacy rate was 88.6% (75% for true-, 100% for partial- and 88.5% for quasi-hyperkeratotic type). No adverse reactions were reported. Drug concentrations in the horny layer were 170.3, 228.5 and 249.2 ng mg-1, respectively, 2, 4 and 12 weeks after starting the treatment. These concentrations are more than 50,000 times higher than the minimum inhibitory concentrations of terbinafine for dermatophytes. These findings indicate that terbinafine HCl (Lamisil) cream is very useful for refractory hyperkeratotic-type tinea pedis when administered alone. The pharmacokinetic data also support the clinical and mycological findings.
Terbinafine was remarkably effective in tinea barbae due to Trichophyton rubrum on the cheek in front of the right ear in a 75-year-old man. This patient also showed tinea pedis and unguium, but these were due to Trichophyton mentagrophytes and were unrelated to the tinea in the cheek. This patient showed an atypical clinical picture slightly different from that during the initial visit, requiring histological differentiation from trichophytic granuloma.
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