Ferrer initiates second phase III clinical study for Ozenoxacin in adult and paediatric patients with impetigo
The multicenter, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approval.
In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.