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

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 No patients were withdrawn from the study because of a lack of healing or worsening of a lesion.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

Cumulative irritation, sensitizing potential, phototoxicity and photoallergy of ozenoxacin in healthy adult volunteers.

In this series of Phase I, randomized, placebo-controlled studies in healthy volunteers, the potential for ozenoxacin 1 and 2% cream formulations to cause irritation, sensitization, phototoxicity and photoallergy under occlusive patch conditions was evaluated. Both ozenoxacin formulations showed excellent dermal tolerability; in the vast majority of cases, only minimal signs of erythema were observed, with no evidence of edema or a papular response. No subject met the criteria for a phototoxic reaction with the ozenoxacin 1 or 2% cream formulations. Only a few adverse events were reported across repeated-dose studies, and virtually all events were considered to be unrelated or unlikely to be related to ozenoxacin application. Ozenoxacin was safe, well tolerated and showed little or no tendency to cause irritation, sensitization, phototoxicity or photoallergy.