title: Systemic bioavailability and safety of twice-daily topical ozenoxacin 1% cream in adults and children with impetigo.
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 No patients were withdrawn from the study because of a lack of healing or worsening of a lesion.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.
authors.affiliation: Ferrer Internacional SA, Av. Diagonal 549, 5th Floor, 08029 Barcelona, Spain.
authors.forename: Savion
authors.initials: S
authors.lastname: Gropper
authors.forename: Ana Luisa
authors.initials: AL
authors.lastname: Cepero
authors.forename: Benjamin
authors.initials: B
authors.lastname: Santos
authors.forename: Dawie
authors.initials: D
authors.lastname: Kruger
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000631:Aminopyridines / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004890:Erythema / Q000209:etiology; D005260:Female; D006801:Humans; D007169:Impetigo / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000209:etiology; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics*; D055815:Young Adult
chemical_list: D000631:Aminopyridines; D000900:Anti-Bacterial Agents; D015363:Quinolones; C000592413:ozenoxacin
keywords: Staphylococcus aureus; Streptococcus pyogenes; impetigo; ozenoxacin; skin infection; systemic absorption