TOPICAL CYPROTERONE-ACETATE TREATMENT IN WOMEN WITH ACNE - A PLACEBO-CONTROLLED TRIAL

Objective: To evaluate the clinical and hormonal response of topically applied cyproterone acetate, oral cyproterone acetate, and placebo lo tion in women with acne. Design: Placebo-controlled, randomized study. Setting: Patients were recruited from the Institute of Endocrine Cosm etics, Vienna, Austria. Patients: Forty women with acne. Interventions : Treatment with oral medication consisting of 0.035 mg of ethinyl est radiol and 2 mg of cyproterone acetate (n=12), 20 mg of topical cyprot erone acetate lotion (n=12), and placebo lotion (n=16) was offered. Pa tients were assessed monthly for 3 months. Main Outcome Measures: Clin ical grading according to acne severity and lesion counts as well as d eterminations of serum cyproterone acetate concentrations. Results: Af ter 3 months of therapy with topical cyproterone acetate, the decrease of mean facial acne grade from 1.57 to 0.67 was significantly better (P<.05) compared with placebo (which showed a change from 1.57 to 1.25 ), but not compared with oral medication (1.56 to 0.75) (P>.05). Lesio n counts also decreased from 35.9 to 9.1 in the topical cyproterone ac etate group compared with oral medication (45.4 to 15.5) (P>.05) and p lacebo (38.2 to 23.1) (P<.05). After topical cyproterone acetate treat ment, serum cyproterone acetate concentrations were 10 times lower tha n those found after oral cyproterone acetate intake. Conclusions: The therapeutic effect of topically applied cyproterone acetate for acne t reatment was clearly demonstrated. Topically applied sexual steroids i n combination with liposomes are as effective as oral antiandrogen med ication in acne treatment, while reducing the risk of adverse effects and avoiding high serum cyproterone acetate concentrations.