Comparative clinical efficacy of shampoos containing ciclopirox olamine (1.5%) or ketoconazole (2%; Nizoral®) for the control of dandruff/seborrhoeic dermatitis

Abstract

The efficacy and acceptability of ciclopirox olamine (1.5%) and ketoconazole (2%; Nizoral®) shampoos were compared in ‘half-head’ (30 subjects with mild dandruff) and in controlled ‘whole-head’ (163 subjects with moderate to severe dandruff and/or seborrhoeic dermatitis) studies. Shampooing was twice weekly. In both studies, an unmedicated shampoo was used during a 2-3 week run-in period, followed by a 4-week double-blind, randomized treatment period. There was a 2-week unmedicated shampoo follow-up period in the whole-head study. A technician assessed the extent and severity of dandruff, the degree of redness and of scaling due to seborrhoeic dermatitis and the area affected, and made a global efficacy evaluation. Subjects self-assessed dandruff, overall scalp itching, itching of the area affected with seborrhoeic dermatitis and dryness/greasiness of their hair, and gave an overall opinion of treatment. The half-head study showed that both medicated shampoos significantly reduced dandruff and scalp itching at 4 weeks with no differences between treatments. The wholehead study showed that ciclopirox olamine, ketoconazole and the control (unmedicated shampoo base) each improved dandruff and/or seborrhoeic dermatitis significantly with both medicated shampoos being equally effective and also superior to the control shampoo at 4 weeks. Between baseline and day 43, the decrease in dandruff score was significantly greater for ketoconazole than for ciclopirox olamine with the difference between treatments being significant. In both studies, ciclopirox olamine (1.5%) was effective in the treatment of scalp disorders and was as well tolerated as ketoconazole.