Ozenoxacin 1% Cream in the Treatment of Impetigo: A Multicenter, Randomized, Placebo- and Retapamulin-Controlled Clinical Trial

Gropper, Savion; Albareda, Nuria; Chelius, Klaus; Kruger, Dawie; Mitha, Ismail; Vahed, Yacoob; Gani, Mashra; García-Alonso, Fernando

doi:10.2217/fmb.14.78

Cited by 40 publications

(63 citation statements)

References 12 publications

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“…Data from this and a previous pivotal phase 3 study 36 demonstrate that ozenoxacin is a rapid, effective new treatment for impetigo. With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin (including MRSA).…”

Section: Discussionmentioning

confidence: 67%

“…These results were statistically significant and consistent with the results of a previously conducted phase 3 clinical trial. 36 When analyzing these data using previously accepted methods for the clinical evaluation of other topical anti-infectives for impetigo, [23][24][25][26]29,30 ozenoxacin demonstrated a 90.1% clinical success rate vs placebo (P = .003). These differences in methods (respective definitions of clinical success shown in Table 2) should be considered when comparing efficacy rates across compounds.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo

Rosen

Albareda

Rosenberg³

et al. 2018

JAMA Dermatol

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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.

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Section: Discussionmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo

Rosen

Albareda

Rosenberg³

et al. 2018

JAMA Dermatol

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“…The efficacy and safety of ozenoxacin 1% cream in the treatment of impetigo have been demonstrated in two pivotal placebocontrolled phase III clinical trials [54,55]. In both studies, placebo consisted of cream vehicle without the active ingredient ozenoxacin.…”

Section: Clinical Efficacymentioning

confidence: 99%

Ozenoxacin: a review of preclinical and clinical efficacy

Vilà

Hebert

Torrelo

et al. 2019

Expert Review of Anti-infective Therapy

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Introduction: Impetigo is the most common bacterial skin infection in children. Treatment is becoming complicated due to the development of antimicrobial resistance, especially in the main pathogen, Staphylococcus aureus. Ozenoxacin, a novel non-fluorinated topical quinolone antimicrobial, has demonstrated efficacy in impetigo. Areas covered: This article reviews the microbiology, pharmacodynamic and pharmacokinetic properties of ozenoxacin, and its clinical and microbiological efficacy in impetigo. Expert opinion: In an environment of increasing antimicrobial resistance and concurrent slowdown in antimicrobial development, the introduction of a new agent is a major event. Ozenoxacin is characterized by simultaneous affinity for DNA gyrase and topoisomerase IV, appears to be impervious to certain efflux pumps that confer bacterial resistance to other quinolones, shows low selection of resistant mutants, and has a mutant prevention concentration below its concentration in skin. These mechanisms protect ozenoxacin against development of resistance, while the absence of a fluorine atom in its structure confers a better safety profile versus fluoroquinolones. In vitro studies have demonstrated high potency of ozenoxacin against staphylococci and streptococci including resistant strains of S. aureus. Clinical trials of ozenoxacin in patients with impetigo reported high clinical and microbiological success rates. Preserving the activity and availability of ozenoxacin through antimicrobial stewardship is paramount.

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“…In the intention to treat population, ozenoxacin was associated with significantly higher clinical success rates than placebo at 34.8% compared with 19.2% (P=0.003); retapamulin's clinical success was similar to ozenoxacin's (37.7%). 73 Ozenoxacin has been tolerated well in studies, with minimal side effects related to the drug.…”

Section: Phase III Agentsmentioning

confidence: 99%

Advances in the medical management of skin and soft tissue infections

McClain

Bohan

Stevens

2016

BMJ

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Skin and soft tissue infections are some of the most common infectious disease diagnoses in both inpatient and outpatient settings. With bacterial resistance to antimicrobials growing, decision making on empiric antibiotics is becoming increasingly difficult. Additionally, the most recent guidance from a professional society on the treatment of skin and soft tissue infections was published in 2014 by the Infectious Diseases Society of America and is now two years old. New antimicrobial agents have been developed and approved for the treatment of skin and soft tissue infections since then, and more are in the pipeline. This review summarizes the evidence on treatments that are new or in development and the potential repurposing of old antimicrobials. The clinical utility of these treatments is also discussed.

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Ozenoxacin 1% Cream in the Treatment of Impetigo: A Multicenter, Randomized, Placebo- and Retapamulin-Controlled Clinical Trial

Abstract: Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.

Cited by 40 publications

References 12 publications

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo

Efficacy and Safety of Ozenoxacin Cream for Treatment of Adult and Pediatric Patients With Impetigo

Ozenoxacin: a review of preclinical and clinical efficacy

Advances in the medical management of skin and soft tissue infections

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