Efficacy and Safety of Ozenoxacin 1% Cream for Topical Treatment of Impetigo in Children and Adults

The document reports on the efficacy and safety of ozenoxacin 1% cream as a novel topical antibiotic treatment for impetigo in children and adults. The development program for ozenoxacin included 17 clinical trials, with two phase 3 randomized, double-blind, multicenter pivotal studies focusing on adult and pediatric patients with impetigo. The results showed that ozenoxacin 1% cream was effective against methicillin-resistant, ciprofloxacin-resistant, and mupirocin-resistant organisms. It demonstrated greater clinical and microbiologic success than a placebo after 5 days of therapy and was generally safe and well-tolerated when applied twice daily for 5 days in children aged 2 months and older and adults up to 83 years of age. The phase 3 studies had limitations, excluding patients with affected areas exceeding 100 cm² or 2% BSA for patients under 12 years old. In conclusion, ozenoxacin 1% cream showed superior clinical and microbiologic response compared to vehicle and had a favorable safety profile, making it a potentially important therapeutic option for impetigo. The study was supported by Medimetriks Pharmaceuticals, Inc., and Ferrer Internacional SA.