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.

• Authors: Antonio Torrelo, Ramon Grimalt, Xavier Masramon, Núria Albareda López, Ilonka Zsolt
• Journal: Dermatology (Basel, Switzerland) (Dermatology) Vol. 236 Issue 3 Pg. 199-207 ( 2020) ISSN: 1421-9832 [Electronic] Switzerland
• PMID: 31958794 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase III, Journal Article)
• Copyright: The Author(s). Published by S. Karger AG, Basel.

Chemical References

• Aminopyridines
• Anti-Bacterial Agents
• Quinolones
• ozenoxacin

Topics

• Administration, Topical
• Adolescent
• Aminopyridines (administration & dosage)
• Anti-Bacterial Agents (administration & dosage)
• Child
• Humans
• Impetigo (drug therapy)
• Quinolones (administration & dosage)
• Skin Cream
• Treatment Outcome