A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED EVALUATION OF SHORT-TERM TREATMENT WITH ORAL ITRACONAZOLE IN PATIENTS WITH TINEA VERSICOLOR

Background: The use of short-term oral azoles is an alternative to top ical 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. Method: Patien ts were randomly assigned to 7 days of treatment with either itraconaz ole, 200 mg once daily, or placebo. A potassium hydroxide examination and assessment of scaling, erythema, pruritus, and global condition we re performed at baseline and at 4 weeks after treatment. Results: The itraconazole-treated group demonstrated significant improvement over b oth baseline (p < 0.01) and placebo (p < 0.02) in scaling, erythema, a nd pruritus. Sixty-seven percent of itraconazole-treated patients were free of symptoms at week 5, as compared with 12% of placebo-treated p atients. Ninety-four percent of itraconazole-treated patients were con sidered to be healed or markedly improved at the study's end point com pared with 6% of placebo-treated patients (p < 0.01). A total of 89% i n the itraconazole-treated group had a negative potassium hydroxide ex amination at the follow-up visit compared with 6% in the placebo-treat ed group (p < 0.01). There was a single report of a possibly treatment -related adverse event in each treatment group. Conclusion: Short-term treatment with itraconazole is effective and well tolerated in the ma nagement of tinea versicolor.