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

<b><i>Background:</i></b> 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. <b><i>Methods:</i></b> Pooled data for patients aged 6 months to &lt;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–&lt;2, 2–&lt;6, 6–&lt;12, and 12–&lt;18 years. <b><i>Results:</i></b> The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (<i>n</i> = 239), vehicle (<i>n</i> = 201), or retapamulin as internal validation control (<i>n</i> = 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 (<i>p</i> &lt; 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. <b><i>Conclusion:</i></b> 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 &lt;18 years.