Systemic bioavailability and safety of twice-daily topical ozenoxacin 1% cream in adults and children with impetigo. (August 2014)

• Record Type: Journal Article
• Authors: Gropper, Savion; Cepero, Ana Luisa; Santos, Benjamin; Kruger, Dawie
• Is Part Of: Future microbiology. Volume 9(2014)Supplement 8
• Page Start: S33
• Page End: S40
• Publication Date: 2014-08
• Subjects: impetigo -- ozenoxacin -- skin infection -- Staphylococcus aureus -- Streptococcus pyogenes -- systemic absorption; Microbiology -- Research -- Periodicals; 616.9041
• DOI: 10.2217/fmb.14.85
• Languages: English
• ISSNs: 1746-0913

Abstract

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 No patients were withdrawn from the study because of a lack of healing or worsening of a lesion.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.