Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo: A Randomized Clinical Trial

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Abstract

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

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