Comparative efficacy and safety of bifonazole 1% cream and the corresponding base preparation in the treatment of seborrhoeic dermatitis

Zienicke H, Korting HC, Braun-Falco O, et al. Comparative efficacy and safety of bifonazole 1% cream and the corresponding base preparation in the treatment of seborrhoeic dermatitis . Mycoses. 1993;36(9-10):325-331.Seborrhoeic dermatitis is a common entity that conventionally is difficult to treat. Recently, topical ketoconazole has been proven successful. To determine if other azoles, and in particular the more modern ones, are also helpful in this condition, a double-blind multicentre randomized controlled trial was performed in patients suffering from seborrhoeic dermatitis involving individuals 16 years and older without human immunodeficiency virus (HIV) infection. One hundred patients were enrolled and treated according to a random plan with either bifonazole 1% cream or the corresponding vehicle once daily for 4 weeks. All patients were evaluated at the beginning of the study, as well as after 2 and 4 weeks, i.e. the treatment period proper, and after 6 weeks of follow-up. Clinical evaluation was based on scores of 0-3 for the following parameters: erythema, papules, infiltration, scaling, itch. In addition, mycological evaluation was performed using adequate contact plates for quantitative determination of Malassezia furfur. In the end, 92 patients were at least partially evaluable. In general, the verum preparation tended to be more efficacious, e.g. the score for erythema amounted to 0.75 after 4 weeks as compared with 0.88 in the control group, the baseline values being 2.18 and 2.04 respectively. With itch, the corresponding figures were 0.17 and 0.33 as compared with 1.42 and 1.38 before treatment. While in statistical terms there was significant difference in these parameters, such a difference was demonstrated by clinical judgement at follow-up. In the verum group (n=37) 10 and 24 patients respectively were cured or improved; the corresponding figures for the control group (n=43) were 9 and 23 (P=0.1). Differences in M. furfur colonization in favour of the verum preparation were not significant. Accordingly, there was no major difference in terms of the overall clinical and mycological cure rate in both groups, originally defined as a major test parameter. Bifonazole 1% cream might be helpful clinically in seborrhoeic dermatitis of non-HIV-infected patients. For definite proof of this hypothesis another confirmatory trial is needed, which should be based solely on global clinical judgement