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

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.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes