Ozenoxacin, a new effective and safe topical treatment for impetigo in children and adolescents
Autor/a
Torrelo, Antonio
Grimalt Santacana, Ramon
Masramon, Xavier
Albareda López, Núria
Zsolt, Ilonka
Data de publicació
2020ISSN
1018-8665
Resum
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.
Tipus de document
Article
Versió del document
Versió acceptada
Llengua
English
Matèries (CDU)
61 - Medicina
Paraules clau
Antibiòtics
Infecció
Pell
Infants -- Salut i higiene
Antibiotics
Infection
Skin
Children -- Health and hygiene
Antibióticos
Infección
Piel
Niños -- Salud e higiene
Pàgines
9
Publicat per
Karger
Publicat a
Dermatology
Citació
Torrelo, Antonio; Grimalt, Ramon; Masramon, Xavier [et al.]. 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.
Aquest element apareix en la col·lecció o col·leccions següent(s)
- Ciències de la Salut [740]
Drets
© 2020 The Author(s). This article is licensed under the Creative Commons AttributionNonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND) (http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission.
Excepte que s'indiqui una altra cosa, la llicència de l'ítem es descriu com https://creativecommons.org/licenses/by-nc-nd/4.0/