Ozenoxacin, a New Effective and Safe Topical Treatment for Impetigo in Children and Adolescents.
| Autor: | Torrelo A; Department of Dermatology, Children's Hospital del Niño Jesús, Madrid, Spain., Grimalt R; Universitat Internacional de Catalunya, Barcelona, Spain., Masramon X; SAIL (Servicio de Asesoría a la Investigación y Logística) SL, Barcelona, Spain., Albareda López N; Clinical Research Department, Ferrer Internacional SA, Barcelona, Spain., Zsolt I; Medical Department, Ferrer Internacional SA, Barcelona, Spain, izsolt@ferrer.com. |
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| Jazyk: | angličtina |
| Zdroj: | Dermatology (Basel, Switzerland) [Dermatology] 2020; Vol. 236 (3), pp. 199-207. Date of Electronic Publication: 2020 Jan 20. |
| DOI: | 10.1159/000504536 |
| Abstrakt: | 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. (The Author(s). Published by S. Karger AG, Basel.) |
| Databáze: | MEDLINE |
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