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

Rosen, Theodore; Albareda, Nuria; Rosenberg, Noah; Alonso, Fernando García; Roth, Sandra P.; Zsolt, Ilonka; Hebert, Adelaide A.

doi:10.1001/jamadermatol.2018.1103

Cited by 47 publications

(48 citation statements)

References 38 publications

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“…The efficacy and safety of ozenoxacin in the paediatric population with non-bullous impetigo were examined by pooling data for patients aged 6 months to < 18 years of age who had participated in phase I [20] or phase III [10,11] clinical trials. In the combined population, clinical and microbiological success rates with ozenoxacin were significantly superior to those with vehicle, confirming the results of the pivotal phase III trials.…”

Section: Discussionmentioning

confidence: 99%

“…The pooled efficacy and safety population consisted of 529 patients aged ≥6 months to < 18 years with non-bullous impetigo who were enrolled in phase I [20] or phase III [10,11] clinical trials of ozenoxacin. Most patients were recruited in South Africa (n = 313), the USA (n = 79), or Germany (n = 60).…”

Section: Demographics and Baseline Clinical Characteristicsmentioning

confidence: 99%

“…As of May 2019, ozenoxacin 1% cream has been approved in 12 countries of the European Union (EU) for topical treatment of non-bullous impetigo in patients aged 6 months and older [9]. Although relatively few patients under 6 months of age and/or with bullous impetigo were enrolled in pivotal phase III clinical trials of ozenoxacin [10,11], in the USA and Canada ozenoxacin 1% cream is indicated for topical treatment of non-bullous and bullous impetigo in patients aged 2 months and older [12,13].…”

Section: Introductionmentioning

confidence: 99%

“…Collectively, these properties suggest that ozenoxacin may be a valuable option for empirical therapy of localised impetigo. Clinical studies of ozenoxacin 1% cream (twice daily for 5 days) demonstrated that it is effective and well tolerated in children and adults with impetigo [10,11,20]. To further ascertain the profile of ozenoxacin specifically in the paediatric population, we extracted and analysed data for children and adolescents aged 6 months to < 18 years who had participated in ozenoxacin clinical trials.…”

Section: Introductionmentioning

confidence: 99%

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

Torrelo

Grimalt

Masramon³

et al. 2020

Dermatology

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Demographics and Baseline Clinical Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Torrelo

Grimalt

Masramon³

et al. 2020

Dermatology

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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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Peceleganan Spray for the Treatment of Skin Wound Infections

Wei,

Li,

et al. 2024

JAMA Netw Open

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ImportancePeceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear.ObjectiveTo assess the safety and efficacy of peceleganan spray for the treatment of wound infections.Design, Setting, and ParticipantsThis multicenter, open-label, phase 3 randomized clinical trial recruited and followed up 570 adult patients diagnosed with secondary open wound infections from 37 hospitals in China from August 23, 2021, to July 16, 2022.InterventionsPatients were randomized to 2 groups with a 2:1 allocation. One group received treatment with 2% peceleganan spray (n = 381) and the other with 1% silver sulfadiazine (SSD) cream (n = 189).Main Outcomes and MeasuresThe primary efficacy outcome was the clinical efficacy rate (the number of patients fulfilling the criteria for efficacy of the number of patients receiving the treatment) on the first day following the end of treatment (day 8). The secondary outcomes included the clinical efficacy rate on day 5 and the bacterial clearance rate (cases achieving negative bacteria cultures after treatment of all cases with positive bacteria cultures before treatment) on days 5 and 8. The safety outcomes included patients’ vital signs, physical examination results, electrocardiographic findings, blood test results, and adverse reactions.ResultsAmong the 570 patients randomized to 1 of the 2 groups, 375 (98.4%) in the 2% peceleganan treatment group and 183 (96.8%) in the 1% SSD control group completed the trial (n = 558). Of these, 361 (64.7%) were men, and the mean (SD) age was 48.6 (15.3) years. The demographic characteristics were similar between groups. On day 8, clinical efficacy was achieved by 339 patients (90.4%) in the treatment group and 144 (78.7%) in the control group (P &lt; .001). On day 5, clinical efficacy was achieved by 222 patients (59.2%) in the treatment group and 90 (49.2%) in the control group (P = .03). On day 8, bacterial clearance was achieved by 80 of 334 patients (24.0%) in the treatment group and in 75 of 163 (46.0%) in the control group (P &lt; .001). On day 5, bacterial clearance was achieved by 55 of 334 patients (16.5%) in the treatment group and 50 of 163 (30.7%) in the control group (P &lt; .001). The adverse events related to the application of peceleganan spray and SSD cream were similar.Conclusions and RelevanceThis randomized clinical trial found that peceleganan spray is a safe topical antimicrobial agent with a satisfactory clinical efficacy rate for the treatment of skin wound infections, while the effectiveness of bacterial clearance remains uncertain.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2100047202

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

Cited by 47 publications

References 38 publications

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

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

Ozenoxacin: a review of preclinical and clinical efficacy

Peceleganan Spray for the Treatment of Skin Wound Infections

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