Systemic ketoconazole in tinea versicolor: a double-blind evaluation and 1-year follow-up.
A 4-week, double-blind comparison of ketoconazole and placebo was conducted in sixty-six patients with tinea versicolor. Two hundred milligrams of ketoconazole in a daily oral dose was effective in producing a clinical and mycologic cure: lesions in thirty-three of thirty-four patients on active drug were completely healed (97%), and one patient had a mild residual effect. Only three patients on placebo were considered to have responded, and none experienced complete healing. Potassium hydroxide (KOH) examinations were negative in all but one of the patients given ketoconazole. All patients receiving ketoconazole who were KOH-negative at week 4 also showed negative results when reexamined 8 weeks later. Patients who did not respond (virtually all of the patients given placebo) were subsequently treated with a topical imidazole lotion. Safety evaluation, including blood chemistry tests and a comprehensive liver function battery, showed no differences between the ketoconazole and placebo groups. Ketoconazole was well tolerated and produced no significant adverse effects. Follow-up after 1 year revealed that 64% of patients given ketoconazole were still clear, whereas only 11% of patients who received placebo (later treated with imidazole topically) were clear after 1 year.
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001772:Blood Cell Count; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D014010:Tinea Versicolor / Q000188:drug therapy*
D007654:Ketoconazole