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.

Topical antibiotics in the dermatological clinical practice: Indications, efficacy, and adverse effects

“…According to this review, the clinical success, defined as total regression or improvement of skin lesions, of Ozenoxacin after 5 days of treatment was confirmed in all age groups, as compared to vehicle (control) 17 . Moreover, microbiological success, defined as the absence of the original pathogens in the bacterial cultures, was also confirmed in all age groups compared to vehicle 17 …”

“…In 2020, Torrelo et al published an interesting review, illustrating the results of phase I and phase III Ozenoxacin clinical trials in 529 nonbullous impetigo patients aged from 6 months to 18 years 17 . According to this review, the clinical success, defined as total regression or improvement of skin lesions, of Ozenoxacin after 5 days of treatment was confirmed in all age groups, as compared to vehicle (control) 17 . Moreover, microbiological success, defined as the absence of the original pathogens in the bacterial cultures, was also confirmed in all age groups compared to vehicle 17 …”

“…The molecular features of Ozenoxacin are extremely promising as it lacks the fluorine atom related to the well-known quinoloneinduced chondrotoxicity, and also exerts a double inhibition on both bacterial DNA gyrase and topoisomerase IV, thus preventing possible resistances 16. In 2020, Torrelo et al published an interesting review, illustrating the results of phase I and phase III Ozenoxacin clinical trials in 529 nonbullous impetigo patients aged from 6 months to 18 years 17. According to this review, the clinical success, defined as total regression or improvement of skin lesions, of Ozenoxacin after 5 days of treatment was confirmed in all age groups, as compared to vehicle (control) 17.…”

The Use of Ozenoxacin in Pediatric Patients: Clinical Evidence, Efficacy and Safety

“…Ozenoxacin [1-cyclopropyl-8-methyl-7-(5-methyl-6-methylaminopyridin-3-yl)-4-oxo-1,4-dihydro-quinoline-3-carboxylic acid] is a novel, nonfluorinated, topical quinolone. It is bactericidal against Gram-positive pathogens, including MRSA, MSSA, MRSE and S. pyogenes, and mupirocin-, and ciprofloxacinresistant strains of S. aureus (Torrelo et al, 2020), inhibiting the enzymes DNA gyrase and topoisomerase IV, both of which are involved in bacterial DNA synthesis (Yamakawa et al, 2002). Its dual inhibitory activity against bacterial replication avoids the development of resistance (Vila et al, 2019); ozenoxacin also has a high accumulation inside Grampositive bacterial cells, apparently due to its resistance to certain efflux pumps commonly found in S. aureus that affect other quinolones (López Cubillos et al, 2018).…”

“…The practical clinical recommendations suggest topical antibiotic therapy for localized lesions and systemic therapy with oral antibiotics in cases of extensive injury, failure or inability to perform topical therapy (Yamakawa et al, 2002;European Medicines Agency, 2014;Health Canada, 2017;U.S. Food and Drug Administration, 2017;Canton et al, 2018;González Borroto et al, 2018;López Cubillos et al, 2018;Tarragó et al, 2018;Vila et al, 2019;Torrelo et al, 2020). The increase in multidrug resistance pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA), mupirocin-resistant Staphylococcus aureus or quinoloneresistant Staphylococcus aureus, requires the development of new antibiotics against these agents.…”