IMPORTANCE: Ozenoxacin, a novel topical antibacterial agent with potent 
bactericidal activity against gram-positive bacteria, has been developed as a 
cream with 1% active drug for the treatment of impetigo, a highly contagious 
bacterial skin infection.
OBJECTIVES: To evaluate the efficacy, safety, and tolerability of ozenoxacin 
cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo.
DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, 
vehicle-controlled clinical trial included patients 2 months or older with 
impetigo who were enrolled at centers in 6 countries from June 2, 2014, through 
May 30, 2015. Data were analyzed based on intention to treat from July 9 through 
July 22, 2015.
INTERVENTIONS: Patients were randomized 1:1 to receive topical ozenoxacin or 
placebo control.
MAIN OUTCOMES AND MEASURES: Efficacy was measured using the Skin Infection 
Rating Scale and microbiological culture. Safety and tolerability were also 
evaluated.
RESULTS: Among the 411 patients who received treatment (210 males [51.1%]; mean 
[SD] age, 18.6 [18.3] years), ozenoxacin demonstrated superior clinical success 
compared with placebo, which was evident after 5 days of therapy (112 of 206 
[54.4%] vs 78 of 206 [37.9%]; P = .001). Ozenoxacin also demonstrated superior 
microbiological success compared with placebo after 2 days of therapy (109 of 
125 [87.2%] vs 76 of 119 [63.9%]; P = .002). Ozenoxacin was well tolerated, with 
8 of 206 patients experiencing adverse effects, with only 1 of these potentially 
related to the study treatment; none were serious.
CONCLUSIONS AND RELEVANCE: Topical ozenoxacin is effective and well tolerated in 
the treatment of impetigo in patients 2 months and older. This effect is 
demonstrated by rapid onset of response and superior clinical and 
microbiological response compared with placebo. Topical ozenoxacin represents a 
novel option for the treatment of impetigo.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02090764.