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 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.
Piérard-Franchimont
C
C
Department of Dermatopathology, University of Liège, Belgium.
Piérard
G E
GE
Arrese
J E
JE
De Doncker
P
P
D000328:Adult; D000368:Aged; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D003881:Dermatomycoses / Q000150:complications / Q000188:drug therapy / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D006203:Hair Preparations; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage*; D008290:Malassezia / Q000302:isolation & purification; D008297:Male; D008875:Middle Aged; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology
D006203:Hair Preparations; D007654:Ketoconazole