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Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

ABSTRACT: BACKGROUND:Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ?6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group. METHODS:Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years. RESULTS:The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days' treatment (day 6-7, end of therapy), and microbiological success rates after 3-4 days' treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption. CONCLUSION:This combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.

SUBMITTER: Torrelo A

PROVIDER: S-EPMC7257257 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

Torrelo Antonio A Grimalt Ramon R Masramon Xavier X Albareda López Núria N Zsolt Ilonka I

Dermatology (Basel, Switzerland) 20200120 3

<h4>Background</h4>Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group.<h4>Methods</h4>Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years.<h4>Results</h4>The combined popu ...[more]

PMID: 31958794

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Project description: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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Dataset Information

Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

Publications

Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.

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