BACKGROUND The use of short-term oral azoles is an alternative to topical therapy in patients with tinea versicolor. OBJECTIVE We compared the efficacy and safety of oral itraconazole with that of placebo in 36 patients with mycologically proven tinea versicolor. METHODS Patients were randomly assigned to 7 days of treatment with either itraconazole, 200 mg once daily, or placebo. A potassium hydroxide examination and assessment of scaling, erythema, pruritus, and global condition were performed at baseline and at 4 weeks after treatment. RESULTS The itraconazole-treated group demonstrated significant improvement over both baseline (p < 0.01) and placebo (p < 0.02) in scaling, erythema, and pruritus. Sixty-seven percent of itraconazole-treated patients were free of symptoms at week 5, as compared with 12% of placebo-treated patients. Ninety-four percent of itraconazole-treated patients were considered to be healed or markedly improved at the study's end point compared with 6% of placebo-treated patients (p < 0.01). A total of 89% in the itraconazole-treated group had a negative potassium hydroxide examination at the follow-up visit compared with 6% in the placebo-treated group (p < 0.01). There was a single report of a possibly treatment-related adverse event in each treatment group. CONCLUSIONS Short-term treatment with itraconazole is effective and well tolerated in the management of tinea versicolor.