IngentaConnect Comparison of single dose 400 mg versus 10-day 200 mg daily dose ...

Abstract:

One hundred and twenty patients were entered into a randomized controlled trial comparing a 400 mg single dose of ketoconazole with a 10-day 200 mg daily dose. The trial was carried out to determine (i) whether the single dose regimen may be effective in tropical conditions such as exist in the Philippines where the relative humidity ranges from 74% to 77% at temperatures of 69-73 °F, and (ii) whether a 400 mg single dose of ketoconazole is as effective as the standard 10-day 200 mg daily dose.

The patients had a moderate degree of infection (25%-50% body surface area using the rule of nines), confirmed by both KOH and Wood's light examinations. They had no topical treatment for 2 weeks and no systemic antifungal intake for at least 1 month prior to the study. Pregnant patients and patients with a history of liver disease were excluded from the study.

One hundred and twenty patients were given either Regimen A (two 200 mg tablets as a single dose) or Regimen B (one 200 mg tablet daily for 10 days). Follow-ups were carried out 10 days and 1 month after completion of each treatment regimen, at which point both KOH and Wood's light examinations were repeated. Mycologic cures were defined as both examinations being negative; treatment failures as either one or both examinations remaining positive.

Considering the low doses used and the relative safety record of ketoconazole in previous studies, blood examinations including liver enzyme determinations were deemed unnecessary.

Fisher's exact test was used to determine the statistical difference between the two regimens at a level of significance of 0.05.

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Comparison of single dose 400 mg versus 10-day 200 mg daily dose ketoconazole in the treatment of tinea versicolor