Investigation of the safety and effectiveness of ozenoxacin lotion (Zebiax® Lotion 2%) in a drug use-results survey in patients with inflammatory acne

Abstract

Ozenoxacin lotion (Zebiax® Lotion 2%) is a topical quinolone antimicrobial agent approved for the treatment of inflammatory acne and superficial skin infections in September 2015. The safety and effectiveness were evaluated in the Drug Use-Results Survey starting in April 2016 with a 12-week observation period for inflammatory acne in clinical practice. From 17 adverse drug reactions observed in 14 out of 1014 cases (1.38%) in the safety analysis set, all were non-serious. The number of facial skin lesions were reduced by a median of 77.3% for inflammatory, 60.0% for non-inflammatory, and 66.7% for total skin lesion count after 12 weeks. With regard to overall improvement at the final evaluation, "markedly improved" and "improved" accounted for 73.0% (737/1010) of facial lesions and 62.1% (59/95) of non-facial lesions, respectively. No influence was observed in the effectiveness by presence or absence of concomitant adapalene and/or benzoyl peroxide at the start of treatment. This may be attributable to each physician in charge having appropriately selected the necessary concomitant therapy depending on the conditions such as severity and the degree of inflammation of skin lesions and, as a result, a high therapeutic effect was observed in all patients. Regarding the safety, there was no influence of concomitant use of adapalene and/or benzoyl peroxide on the onset of adverse reactions of this drug. These results indicate that ozenoxacin lotion (Zebiax® Lotion 2%) is useful in acute-phase treatment of inflammatory acne in real clinical settings.