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Original Investigation
June 13, 2018

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With ImpetigoA Randomized Clinical Trial

Author Affiliations
  • 1Department of Dermatology, Baylor College of Medicine, Houston, Texas
  • 2Ferrer Internacional, SA, Barcelona, Spain
  • 3Medimetriks Pharmaceuticals, Inc, Fairfield, New Jersey
  • 4John P. and Katherine G. McGovern Medical School, Houston, Texas
JAMA Dermatol. Published online June 13, 2018. doi:10.1001/jamadermatol.2018.1103
Key Points

Question  Is topical ozenoxacin safe and effective for patients with impetigo?

Findings  In this randomized, clinical trial of 412 patients, 112 of 206 (54.4%) achieved an effective clinical response and 115 of 125 (92.0%) achieved a microbiological response after 5 days of treatment with ozenoxacin cream, 1%, compared with placebo. Microbiological success was observed after 2 days of therapy.

Meaning  In patients 2 months and older, ozenoxacin cream, 1%, appears to be effective and well tolerated for the treatment of impetigo, confirming the results of the first pivotal study.

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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