A comparison of fluconazole with ketoconazole, itraconazole, and clotrimazole in the treatment of patients with pityriasis versicolor

Abstract

Pityriasis versicolor is a superficial recurring mycotic infection frequently encountered in tropical countries. The challenge for clinicians is selecting an antifungal therapy that produces long-lasting cure, good patient compliance, and a low incidence of adverse effects. Three open-label, randomized, comparative multicenter studies were conducted in South America to assess the efficacy and safety of fluconazole (two 300-mg doses given 1 week apart, and, if necessary, a third dose given 1 week later) with those of ketoconazole (200 mg daily for 10 or 14 days), itraconazole (200 mg daily for 7 days), or clotrimazole 1% cream (two applications daily for 21 days) in the treatment of patients with mycologically proven pityriasis versicolor. Clinical signs and symptoms of skin infection and microscopic examination and cultures of lesion scrapings were assessed at baseline and on days 14, 30 (or 37 for patients who received the third fluconazole dose), and 60. Safety was assessed on days 7, 14, 30 (or 37 for patients who received the third fluconazole dose), and 60. A total of 388 patients received study drug: 194 in the three fluconazole groups and 194 in the ketoconazole, itraconazole, and clotrimazole comparator groups. The combined clinical response rate (cure plus improvement) at early follow-up (day 14) in the fluconazole treatment groups was 91.2%, a response that was maintained at the day 60 evaluation. Similar clinical response rates were found among patients treated with the comparator drugs. Although the eradication rate at day 14 was significantly lower in the fluconazole group (39.1%) than in the itraconazole group (56.5%), no significant differences in eradication rate between fluconazole and each of the comparator drugs were found at later follow-up assessments (days 30 and 60). The highest rate of reinfection (15.3%) was found in itraconazole-treated patients at day 60. The incidence of adverse events was low in all treatment groups, and no clinically significant laboratory abnormalities were reported. The results of these studies indicate that fluconazole administered as two or three weekly 300-mg doses to patients with pityriasis versicolor was well tolerated and at least as effective as accepted regimens employing ketoconazole, itraconazole, and topical clotrimazole. This fluconazole regimen represents an attractive alternative to prolonged daily oral or topical therapy.