A randomized Comparison of Ketoconazole Lotion and Ketoconazole Cream for the Treatment of Seborrheic Dermatitis-R41400-L Clinical Research Group for Seborrheic Dermatitis-

Accession number;03A0323479
Title;A randomized Comparison of Ketoconazole Lotion and Ketoconazole Cream for the Treatment of Seborrheic Dermatitis-R41400-L Clinical Research Group for Seborrheic Dermatitis-
Author; IGARASHI ATSUYUKI (Ntthigashinihon Kantobyoin Hifuka) HARADA SHOTARO (Higashi-Nihon Denshin Denwa, Kanto Byoin) TODA KIYOSHI (Todahifukakurinikku)
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.19;NO.4;PAGE.355-369(2003)
Figure&Table&Reference;FIG.9, TBL.5, REF.13
Pub. Country;Japan
Language;Japanese
Abstract;The purpose of the study was to examine the efficacy and safety of 2% ketoconazole lotion in patients with seborrheic dermatitis. A total of 141 patients were enrolled in a randomized study comparing 2% ketoconazole lotion and those of 2% ketoconazole cream. Of the 141 patients that were enrolled, 2 of them were excluded from all analysis and 15 from the analysis of efficacy. Consequently, 139 patients were evaluated for safety, and 124 patients for efficacy. For the efficacy rates, percentages of .GEQ. "effective", were 73.8% in the ketoconazole lotion group and 71.4% in the ketoconazole cream group, showing no significant difference. And on scalp area, they were 70.6% and 65.6%. Also for the average of symptom score, no difference was noted either at week 2 or at week 4 between two groups. For the convenience of applying of the topical agents on scalp area, percentages of "convenience", were 75.7% in the ketoconazole lotion group and 58.3% in the ketoconazole cream group. Adverse events whose causal relation to the study medication could not be ruled out were reported for 11 patients in the ketoconazole lotion group and 7 patients in the ketoconazole cream group, showing no significant difference between the groups. The study shows that the efficacy of ketoconazole lotion was not inferior to that of ketoconazole cream. We concluded that ketoconazole lotion would be useful for the treatment of seborrheic dermatitis and can be conveniently applied to scalp. (author abst.)