Phase III trial of ozenoxacin for impetigo shows drug superiority over placebo- Ferrer Int

Ferrer International successfully completed the second Phase III clinical trial for ozenoxacin, a topical treatment for adult and paediatric patients with impetigo, a highly contagious bacterial skin infection. The study, which involved ozenoxacin formulated as a topical treatment for dermatological infectious conditions in adults and peadiatric patients aged 2 months and older, demonstrated the superiority of ozenoxacin 1% cream, applied twice daily for 5 days, versus placebo on both the clinical and bacteriological endpoints by end of therapy visit (day 6–7).

In addition, ozenoxacin 1% cream demonstrated superior bacteriological cure compared to placebo as early as visit 2 (day 3–4). Ozenoxacin 1% cream was shown to be safe and well tolerated in the adult and paediatric population. The trial was conducted at 44 centres in the United States, Puerto Rico, South Africa, Germany, Romania, Russia, and Spain, and involved 412 adult and paediatric patients aged 2 months and older with a clinical diagnosis of bullous or non-bullous impetigo.