Ketoconazole (KET) is active to control dandruff and seborrhoeic dermatitis. Objective assessments comparing the 1% and 2% shampoo formulations are scant. This open, randomized parallel-group trial was carried out to differentiate the effectiveness of KET 1% and 2% in severe dandruff and seborrhoeic dermatitis. A total of 66 patients with severe dandruff or seborrhoeic dermatitis were randomized to each of the two groups. A 2-week run-in phase was followed by a 4-week treatment phase, in turn followed by a 4-week follow-up. The efficacy of treatments was evaluated by combining squamometry X, Malassezia spp. counts and clinical assessments. After 2 and 4 weeks of treatment, KET 2% was significantly superior over KET 1% (p < 0.001) for decreasing both in flakiness and Malassezia density from baseline. The same trend was observed in the mean change from baseline in the overall dandruff severity score. Only 6 mild adverse events were reported. During follow-up KET 2% showed a trend to fewer relapses than KET 1%. KET 2% had superior efficacy compared to KET 1% in the treatment of severe dandruff and scalp seborrhoeic dermatitis. Biometrological evaluations were correlated with the clinical improvements and therefore useful to incorporate in future dandruff studies.
Copyright 2001 S. Karger AG, Basel.