Ozenoxacin, a new effective and safe topical treatment for impetigo in children and adolescents
Albareda López, Núria
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.
61 - Medicina
Infants -- Salut i higiene
Children -- Health and hygiene
Niños -- Salud e higiene
Is part of
Torrelo, Antonio; Grimalt, Ramon; Masramon, Xavier; Albareda López, Núria; Zsolt, Ilonka. Ozenoxacin, a new effective and safe topical treatment for impetigo in children and adolescents. Dermatology, 2020, p. 1-9. Disponible en: <https://www.karger.com/Article/Abstract/504536>. Fecha de acceso: 1 mar. 2020. DOI: 10.1159/000504536.