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.

Aim: To compare the in vitro activity of the anti-impetigo agent, ozenoxacin, and other antimicrobial agents against Gram-positive clinical isolates from skin and soft tissue infections. Materials & methods: Isolates were collected in two studies: 1097 isolates from 49 centers during 2009–2010 and 1031 isolates from ten centers during 2014. Minimum inhibitory concentrations were determined for 18 and 11 antimicrobials in these studies, respectively, using standard broth microdilution methods. Isolates were stratified by species and methicillin susceptibility/resistance and/or levofloxacin susceptibility/nonsusceptibility status. Results: Ozenoxacin exhibited high in vitro activity against Staphylococcus aureus and coagulase-negative staphylococci isolates in both studies. Ozenoxacin was also highly active against Streptococcus pyogenes and Streptococcus agalactiae isolates. Conclusion: Ozenoxacin is a potent antimicrobial agent against staphylococci and streptococci.

Aim: To explore the antibacterial spectrum of ozenoxacin and compare its in vitro activity with that of other antibacterial agents. Materials & methods: In 2010, 10,054 isolates were collected from...

Several acne grading systems have been described, but consensus is lacking on which shows superiority. A standardized system would facilitate therapeutic decisions and the analysis of clinical trial data. To assess the feasibility, reliability, validity and sensitivity to change of the Spanish Acne Severity Scale (EGAE). A Spanish, multicentre, prospective, observational study was performed in patients with facial, back or chest acne assessed using EGAE, Leeds Revised Acne Grading system (LRAG) and lesion count. Clinicians answered 4 questions regarding EGAE use and time employed. Patients were evaluated at baseline and after 5±1 weeks. Four additional blinded observers, all dermatologists, evaluated patients' pictures using EGAE and LRAG. In total, 349 acne locations were assessed in 328 patients. Of the dermatologists, 95.6% (CI: 92.9-97.5%) reported that EGAE was easy to use, and 75% used it in 0.85; p<0.001). EGAE mean score in treatment-compliant patients was significantly lower at follow-up than at baseline (2.14 vs. 1.57, p<0.001, Cohen's d=0.35).The pre-post-treatment difference in EGAE mean score in non-compliant patients was not significant (1.44 vs. 1.32, p<0.102) and Cohen's d was lower (0.19) than in compliant patients. The use of EGAE to evaluate acne grade in daily clinical dermatological practice in Spanish centres has shown feasibility, high interobserver reliability, concurrent validity and sensitivity to detect treatment effects.

Aim: Ozenoxacin is a nonfluorinated quinolone antibacterial approved for topical treatment of impetigo. Because quinolones have known chondrotoxic effects in juvenile animals, the potential toxicity of ozenoxacin was assessed in preclinical studies. Materials & methods: Ozenoxacin or ofloxacin (300 mg/kg/day for 5 days, for each compound) was orally administered to juvenile rats, and oral ozenoxacin (10–100 mg/kg/day for 14 days) was administered to juvenile dogs. Results: In juvenile rats, ozenoxacin showed no chondrotoxicity, whereas ofloxacin produced typical quinolone-induced lesions in articular cartilage in three of ten rats. Oral ozenoxacin administration to juvenile dogs showed no chondrotoxicity or toxicologically relevant findings in selected target organs. Conclusion: Ozenoxacin was generally well-tolerated in juvenile rats and dogs, with no evidence of quinolone-induced arthropathy.

Ozenoxacin is a topical antibiotic approved in the United States for treatment of impetigo in adults and children age ≥2 months. This analysis evaluated the efficacy and safety of ozenoxacin in specific pediatric age groups. Data for children aged 2 months to <18 years recruited from eight countries who had participated in phase 1 and 3 trials of ozenoxacin were extracted and analyzed by age range. Across studies, 644 pediatric patients with impetigo received ozenoxacin 1% cream (n = 287) or vehicle (n = 247). One study included retapamulin 1% ointment as the internal validity control (n = 110). The clinical success rate at the end of treatment and bacterial eradication rates after 3 to 4 days of treatment and at the end of treatment were significantly higher with ozenoxacin than vehicle (all p < .0001). The clinical and microbiologic success rates were higher with ozenoxacin than vehicle in the age groups of 0.5 to <2 years, 2 to <6 years, 6 to <12 years, and 12 to <18 years and were comparable to vehicle in the 2 to <6 months age group, although patient numbers were low (≤5 per treatment arm). No safety concerns with ozenoxacin were identified. Of the 362 plasma samples derived from 38 patients, four slightly exceeded the lower limit of quantification, indicating negligible systemic absorption. The results of this analysis suggest that ozenoxacin 1% cream is an effective and safe treatment for impetigo in pediatric patients aged 2 months to <18 years.