OZENOXACIN has been shown to be a well-tolerated and effective treatment for impetigo patients ≥2 months old, according to results of a randomised, double-blind, vehicle-controlled Phase III clinical trial involving 412 patients. This potent, novel 1% antibacterial cream showed clinical and microbiological responses superior to those of placebo and also demonstrated an ability to eradicate drug-resistant organisms.
During the Phase III study, remarkable improvements in treated lesions were observed. Clinical success was identified after 5 days of treatment in 54.4% and 37.9% of patients randomised to ozenoxacin and placebo, respectively (p=0.001), which was defined as complete absence of the treated lesion. Microbiologic response was found in 87.2% versus 63.9% of patients at Day 3 of treatment with ozenoxacin and placebo, respectively (p=0.002). At the end of therapy (Day 6), response rates were 92.0% and 73.1%, respectively (p=0.005).
These results are even more poignant considering most clinicians do not know the strain or resistance potential of the bacteria at the time of initial treatment. During this study, all patients with drug-resistant infections had clinical cure or at least some level of improvement when treated with ozenoxacin, including 10 patients with mupirocin-resistant Staphylococcus aureus and 8 with methicillin-resistant S. aureus (MRSA). Adverse events were limited for both groups, indicating the treatment was well tolerated and a viable option for impetigo patients.
Study author Dr Theodore Rosen, Baylor College of Medicine, Houston, Texas, USA, commented on the importance of ozenoxacin in this antibiotic-resistant age: “With concerns over widespread antibiotic resistance, ozenoxacin is an important potential treatment option with an expanded spectrum against bacterial pathogens, including those resistant to mupirocin, ciprofloxacin, and methicillin, including MRSA.”