A randomised, single-blind, single-centre clinical trial to evaluate comparative clinical efficacy of shampoos containing ciclopirox olamine (1.5%) and salicylic acid (3%), or ketoconazole (2%, Nizoral ® ) for the treatment of dandruff/seborrhoeic dermatitis

BACKGROUND : The association between seborrhoeic dermatitis and dandruff and the yeast Malassezia furfur is well recognized. Symptoms include scalp itchiness and scaling. Due to its antimycotic activity, ciclopirox olamine is established as an effective treatment for these scalp conditions. Salicylic acid has keratolytic properties and aids in the removal of scales. OBJECTIVE : To compare the therapeutic efficacy of a shampoo containing 1.5% ciclopirox olamine and 3% salicylic acid (CPO/SA) with Nizoral ® (2.0% ketoconazole shampoo) in a study involving 154 subjects with dandruff - 70 of whom also had seborrhoeic dermatitis of the scalp. Nizoral ® is currently a registered treatment for dandruff and seborrhoeic dermatitis. METHODS : The shampoos were used three times week for 4 weeks, with 2-week washout and follow-up periods. Clinical and self-assessments were made throughout treatment and after follow-up (day 43). Within and between-treatment assessments of signs and symptoms were analysed. RESULTS : In the two groups, seborrhoeic dermatitis and dandruff improved significantly throughout treatment, with lower clinical and self-assessment scores at both the end of treatment (day 29) and follow-up (day 43). Only the subjects treated with CPO/SA shampoo showed a significant reduction in the itching of seborrhoeic dermatitis at these times. CONCLUSION : The study demonstrated that both CPO/SA and Nizoral ® were safe and effective in the treatment of dandruff and seborrhoeic dermatitis.