Systemic bioavailability and safety of twice-daily topical ozenoxacin 1% cream in adults and children with impetigo

Future Microbiol. 2014;9(8 Suppl):S33-40. doi: 10.2217/fmb.14.85.

Abstract

In this Phase I open-label study, the systemic absorption, clinical response, safety and tolerability of multiple-dose ozenoxacin 1% cream were evaluated in children (≥ 2 months of age) and adults with impetigo. A single (evening) dose of ozenoxacin 1% cream on day 1 was followed by twice-daily application for 4 days (every 12 h), and then a final single (morning) dose on day 6. A total of 46 patients were enrolled in the study. The majority of ozenoxacin plasma samples were below the limit of quantification (no systemic absorption). Approximately half (22/45) of the evaluable patients achieved clinical success (skin lesions were cured). No patients were withdrawn from the study because of a lack of healing or worsening of a lesion. Ozenoxacin was well tolerated in all patients.

Keywords: Staphylococcus aureus; Streptococcus pyogenes; impetigo; ozenoxacin; skin infection; systemic absorption.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aminopyridines / administration & dosage
  • Aminopyridines / adverse effects*
  • Aminopyridines / pharmacokinetics*
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Erythema / etiology
  • Female
  • Humans
  • Impetigo / drug therapy*
  • Male
  • Middle Aged
  • Pruritus / etiology
  • Quinolones / administration & dosage
  • Quinolones / adverse effects*
  • Quinolones / pharmacokinetics*
  • Young Adult

Substances

  • Aminopyridines
  • Anti-Bacterial Agents
  • Quinolones
  • ozenoxacin