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KETOCONAZOLE 2% DANDRUFF SHAMPOO "BETTER TOLERATED"

This article was originally published in The Tan Sheet

Executive Summary

KETOCONAZOLE 2% DANDRUFF SHAMPOO "BETTER TOLERATED" than a selenium sulfide 2.5% shampoo for the treatment of moderate to severe dandruff, according to a study by William Danby, MD, et al. appearing in the December issue of the Journal of the American Academy of Dermatology. The study authors concluded that "both ketoconazole 2% shampoo and selenium sulfide 2.5% shampoo are effective in the treatment of moderate to severe dandruff; however, ketoconazole 2% shampoo appears to be better tolerated." The randomized, double-blind, placebo-controlled study was conducted by researchers from Queen's University in Kingston, Ontario, the University of British Columbia in Vancouver, and McMaster University in Hamilton, Ontario. The trial was supported by Janssen Pharmaceutica, which manufactures prescription Nizoral (ketoconazole 2%) shampoo. In the trial, 97 of the 246 patients used ketoconazole shampoo, 100 used selenium sulfide shampoo and 49 used a placebo. All of the patients had moderate to severe dandruff, and about one-third had seborrheic dermatitis. The study included a two-week wash-out period in which participants used a nonmedicated shampoo two times a week at home. After two weeks, a dandruff assessment was performed, and patients with a dandruff score higher than 14 were eligible to enter the four-week treatment period during which patients were shampooed twice a week by a technician and evaluated three days after the day one shampooing and at weeks one, two and four. Patients who responded to treatment were eligible to enter a three-week follow- up period in which they shampooed at home twice a week with the nonmedicated shampoo and were assessed on a weekly basis. "Ketoconazole was significantly better than selenium at day eight only," the authors reported. However, they found that "both medicated shampoos were significantly better than placebo, but not significantly different from each other." Researchers visually examined six areas of a patient's scalp to evaluate adherent and loose dandruff. The patients also were examined for irritation and itching, global improvement and the presence of yeast cells. Approximately one-third of the patients in each group had irritation at baseline. At the end of the treatment period, patients using the medicated shampoos reported increased irritation. Regarding global improvement, patients in the treatment groups showed higher scores than those in the placebo group. The researchers also found that the ketoconazole and selenium sulfide shampoos decreased the percentage of patients with detectable yeast cells by 59.4% and 48%, respectively, versus an 11% increase in the placebo group. Fourteen patients reported 15 adverse reactions -- nine during the treatment period and six during the follow-up phase. All of the adverse experiences occurred in the selenium sulfide group. The reactions included pruritus, eruption near the hair line, psoriasis, lightening or bleaching of the hair, orange staining of the scalp and a chemical taste while shampooing.
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