Effect of ketoconazole 1% and 2% shampoos on severe dandruff and seborrhoeic dermatitis: Clinical, squamometric and mycological assessments

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 followup 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 <(c)> 2001 S. Karger AG, Basel.