A RANDOMIZED,DOUBLE-BLIND,PLACEBO-CONTROLLED CLINICAL TRIALS OF 2% KETOCONAZOLE SHAMPOO IN THE TREATMENT OF DANDRUFF,SEBORRHEIC DERMATITIS AND TINEA VERSICOLOR

Ketoconazole is a highly effective agent against the yeast Malassizia furfur (Pityrosporum ovale),an organism which was believed to play an important role in the pathogenesis of dandruff and seborrheic dermatitis. Tinea versicolor is also caused by M. furfur. This study was to evaluate the safety and effectiveness of 2% ketoconazle shampoo and placebo shampoo in patients with dandruff.seborrheic dermatitis and tinea versicolor.A total of 216 patients were included. The results of this study indicate that 2% ketoconazole shampoo were significantly better than placebo. Of 50 patients with dandruff, 66.0% were cured and excellent to the symptom of dandruff(placebo43.9%,P0.05);71.7% toitching of the scalp(placebo 30.0%,P0.01);total efficacy rate were 70.0%(placebo 39.0%, P0.01).Of 42 patients with seborrheic dermatitis,63.2% were cured and excellent to the symptom of dandruff(placebo 34.4%, P0.05),33. 3% to erythema of the scalp(placebo 22.7%,P 0.05), 68. 6% to seborrhea of hair(placebo 26.5%, P0.01); 50.0% to itching of the scalp (placebo 23.5%, P0.05);total efficacy rate were 57.1%(placebo 24. 3%, P0.01). Of 23 patients with tinea versicolor,cure rate were 82.6%(placebo 17.4%, P0.0001). 2% Ketoconazole shampoo is well tolerated,the adverse effects were 1.7%(placebo 3.0%, P0.05),such as irritation and exacerbation.